AzTrials
AzTrials

Systemic Inflammatory Response SyndromePhase 4NCT05172739

Opioid Free Anaesthesia-Analgesia Strategy on Surgical Stress and Immunomodulation in Elective VATS-Lobectomy for NSCLC

A Phase 4 study testing Opioid-Based Anesthesia-Analgesia Strategy and Opioid-free Anesthesia-Analgesia Strategy in people with Systemic Inflammatory Response Syndrome and Postoperative Pain, Acute, run by University of Crete at 1 site in Greece.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

Lobectomy is a major, high-risk surgical procedure that in addition to one-lung ventilation (OLV) exerts a potent surgical stress response. An overwhelming immune cell recruitment may lead to excessive tissue damage, peripheral organ injury and immunoparesis. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Opioid-Based Anesthesia-Analgesia Strategy and Opioid-free Anesthesia-Analgesia Strategy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteGreece
Study dates
1 Oct 2021to 1 Nov 2026
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • patients undergoing elective VATS lobectomy
  • early stage NSCLC (up to T3N1M0)

Who cannot join

  • Immunocompromised patients
  • previous lung surgery
  • preoperative corticosteroid or immunosuppressive drug use
  • uncontrolled Diabetes Mellitus
  • cardiac failure (NYHA 3 and 4)
  • preoperative infection (CRP >5mg/ml, WBC >10x10^9/L)
Show all 12Show fewer
  • preoperative anemia (Hb<12g/dl)
  • chronic inflammatory diseases
  • inflammatory bowel disease
  • Group-specific exclusion criteria:
  • OFA-Α: perioperative opioid administration, within the study period
  • OBA-Α: perioperative dexmedetomidine or lidocaine infusion, ketamine, gabapentinoid or corticosteroid administration within the study period

Trial locations and contacts

1 site in 1 country.

Periklis Vasilos, MD contact

00306978702023

p.vassilos@gmail.com

Georgios Stefanakis, MD, PhD contact

00306978779726

G_Stefanakis@yahoo.com

Greece1 site, 1 recruiting

  • University of Crete

    Heraklion, Crete, 71110

    Periklis Vasilos, MD, 00306978702023, p.vassilos@gmail.com

    Recruiting

Other trials in Greece

About this study

Official title: Effect of a Perioperative Opioid Free Anaesthesia-Analgesia (OFA-A) Strategy on Surgical Stress Response and Immunomodulation in Elective VATS Lobectomy for NSCLC Lung Cancer: A Prospective Randomized Study

Lobectomy is a major, high-risk surgical procedure that in addition to one-lung ventilation (OLV) exerts a potent surgical stress response. An overwhelming immune cell recruitment may lead to excessive tissue damage, peripheral organ injury and immunoparesis. The effect of anesthesia on the immune system is modest, compared to the effects induced by major surgery. However, to an immunocompromised patient, due to cancer and/or other comorbidities, the immunosuppressive effects of anesthesia may increase the incidence of post-operative infections, morbidity, and mortality. Exogenous opioids have been correlated with immunosuppression, opioid-induced hyperalgesia, and respiratory depression, with deleterious outcomes. An Opioid-Free Anaesthesia-Analgesia (OFA-A) strategy is based on the administration of a variety of anaesthetic/analgesic and other pharmacological agents with different mechanisms of action, including immunomodulating and anti-inflammatory effects. Our basic hypothesis is that the implementation of a perioperative multimodal OFA-A strategy, will lead to an attenuated surgical stress response and attenuated immunosuppression, compared to a conventional Opioid-Based Anaesthesia-Analgesia (OBA-A) strategy. The aforementioned effects, are presumed to be associated with equal or improved analgesia and decreased incidence of postoperative infections compared to a perioperative OBA-A technique.

Read the detailed description

Surgical manipulation and one lung ventilation (OLV) exert different and synergic effects to generate an inflammatory response during lung resection surgery. Surgery, such as lobectomies, often leads to severe immunosuppression that in turn can lead to infectious complications and sepsis. Both anesthesia-related and surgery-related perioperative measures may modulate the patient's immune response and lead to the activation of different components of the immune system. Anesthesia-induced activation, in particular of the adaptive immune system, may also induce persistent, postoperative immunosuppression. An overwhelming immune cell recruitment may lead to excessive tissue damage, peripheral organ injury and immunoparesis.

Opioid analgesia remains the corner stone of acute pain management in perioperative analgesic regimes. Opioid receptors are not only expressed in the central nervous system to regulate pain perception but also occur on immune and tumour cells. Exogenous opioid administration has been correlated with immunosuppression, opioid-induced hyperalgesia, and respiratory depression, with deleterious outcomes.

An Opioid-Free Anaesthesia-Analgesia (OFA-A) strategy is based on the administration of a variety of anaesthetic/analgesic and other pharmacological agents with different mechanisms of action, including immunomodulating and anti-inflammatory effects where at least one factor causes inhibition of central sensitization and at least another factor inhibits the peripheral sensitization of the nervous system, as a response to painful surgical stimuli. This combination of factors has to have a synergistic or additive effect so that best analgesic effects can be achieved with the lowest possible dosage.

Our basic hypothesis is that a perioperative OFA-A strategy on cancer patients undergoing VATS lung surgery for tumour resection will be accompanied by abolished or attenuated immunosuppression. The additional potential clinical implication of a perioperative OFA-A strategy is the avoidance of the onco-proliferative side effects of both exogenous and endogenous opioids, released by cytokine-mediated immune cell activation. Inflammatory response inhibition is expected to reduce the possibility of acute and chronic post-operative pain developement, compared to a perioperative Opioid-Based Anaesthesia- Analgesia (OBA-A) technique. Additionally, the aforementioned inflammatory response inhibition is expected to lead to an overall reduction of overall postoperative pulmonary complications.

Being tested
Opioid-Based Anesthesia-Analgesia Strategy, Opioid-free Anesthesia-Analgesia Strategy
Keywords
Opioid-free Anesthesia-Analgesia, Opioid-based Anesthesia-Analgesia, Cytokines, NSCLC, Hemodynamic stability, Immunomodulation, Inflammatory markers, Acute postoperative pain, Chronic postoperative pain
Medical subject headings
Systemic Inflammatory Response Syndrome, Pain, Postoperative, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Opioid-Based Anesthesia-Analgesia StrategyDrug

    Also called Opioid-Based Anesthesia, OBA-A

    A perioperative Opioid-Based multimodal Anesthesia- Analgesia strategy will be implemented that incorporates the following pharmacological agents:

    Premedication: Midazolam, Anaesthesia induction \& maintenance: Midazolam, Propofol, Fentanyl, Cisatracurium or alternatively Rocuronium, Desflurane, Morphine, Paracetamol, Dexketoprofen trometamol, Ondansetron or Droperidol, Ropivacaine Surgical ward: Morphine, Paracetamol, Dexketoprofen trometamol Rescue therapy only: Tramadol

  • Opioid-free Anesthesia-Analgesia StrategyDrug

    Also called Opioid-Free Anesthesia, OFA-A

    A perioperative Opioid-Based multimodal Anesthesia- Analgesia strategy will be implemented that incorporates the following pharmacological agents:

    Premedication: Pregabalin, Midazolam, Anesthesia induction \& maintenance: Midazolam, Dexmedetomidine, Lidocaine, Propofol, Ketamine, Hyoscine, Cisatracurium or alternatively Rocuronium, Magnesium sulphate, Dexamethasone, Desflurane, Paracetamol, Dexketoprofen trometamol, Ondansetron or Droperidol, Ropivacaine, Surgical ward: Ketamine, Lidocaine, Clonidine, Droperidol and Midazolam, Pregabalin, Paracetamol, Dexketoprofen trometamol Rescue therapy only: Tramadol

Study groups in NCT05172739
Study groupRoleWhat they receive
Opioid-Based Anaesthesia AnalgesiaActive comparatorPremedication: IM Midazolam 0.05-0.07mg/kg. Anesthesia induction: Midazolam 0.03mg/kg, Propofol 2-3mg/kg, Fentanyl 1-2mcg/kg and Cisatracurium 0.2mg/kg or alternatively Rocuronium 0.6-1.2mg/ kg. Anesthesia maintenance: Desflurane set at approximately 1 MAC, Morphine 0.1-0.12mg/kg, Fentanyl 1-2mcg/kg during induction and 50-100mcg prn, Paracetamol 1g +/- Dexketoprofen trometamol 50mg, along with Ondansetron 4mg or Droperidol 0.625mg. Wound infiltration: Ropivacaine 75-150mg. Surgical ward: PCA pump with Morphine for the first 3 postoperative days. Additional postoperative analgesia: Paracetamol 1g 1x3 +/- Dexketoprofen trometamol 50mg 1x2. Rescue therapy only: Tramadol 50-100mg.
Receives: Drug: Opioid-Based Anesthesia-Analgesia Strategy
Opioid-Free Anesthesia AnalgesiaActive comparatorPremedication: Pregabalin 150mg 1x2, IM Midazolam 0.05-0.07mg/kg. Anesthesia induction: Midazolam 0.03mg/kg, Dexmedetomidine 0.5-1mcg/kg, Lidocaine 1mg/kg, Propofol 2-3mg/kg, Ketamine 1-1.5mg/kg, Hyoscine 10mg, Cisatracurium 0.2mg/ kg or alternatively Rocuronium 0.6-1.2mg/kg, Magnesium sulphate 2.5-5g and Dexamethasone 8-16mg. Anesthesia maintenance: Desflurane set at ~1 MAC, Dexmedetomidine 0.5-1.2mcg/kg/h, Lidocaine 0.5-1mg/kg/h, Ketamine 0.3-0.5mg/kg prn, Paracetamol 1g +/- Dexketoprofen trometamol 50mg, and Ondansetron 4mg or Droperidol 0.625mg. Wound infiltration: Ropivacaine 75-150mg. Surgical ward: PCA pump with Ketamine, Lidocaine, Clonidine, Droperidol and Midazolam for the first 3 postoperative days. Additionally, Pregabalin 50mg per os 1x1 and 25mg 1x1, Paracetamol 1g 1x3 +/- Dexketoprofen trometamol 50mg 1x2. Rescue therapy only: Tramadol 50-100mg.
Receives: Drug: Opioid-free Anesthesia-Analgesia Strategy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Neutrophil to Lymphocyte ratio (NLR)

    Neutrophil to Lymphocyte ratio (NLR) is a prognostic index that predicts patients' overall survival. Higher NLR has been correlated with worse outcome.

    Measured: Preoperatively

  2. Platelet to Lymphocyte ratio (PLR)

    Platelet to Lymphocyte ratio (PLR) is a prognostic index that predicts patients' overall survival. Higher PLR has been correlated with worse outcome.

    Measured: Preoperatively

  3. Lymphocyte to monocyte ratio (LMR)

    Lymphocyte to monocyte ratio (LMR) is a prognostic index that predicts patients' overall survival. Lower LMR has been correlated with worse outcome.

    Measured: Preoperatively

  4. Advanced Lung Cancer Inflammation Index (ALI)

    Advanced Lung Cancer Inflammation Index (ALI) is a prognostic index that predicts patients' recurrence-free survival and overall survival. ALI is calculated as (BMI x Alb / NLR) where BMI = body mass index, Alb = serum albumin, NLR (neutrophil lymphocyte ratio, a marker of systemic inflammation). Higher ALI scores have been correlated with worse outcome.

    Measured: Preoperatively

  5. Systemic Immune Inflammation Index (SII)

    Systemic Immune Inflammation Index (SII) is a prognostic index that predicts patients' overall survival. SII is calculated as follows: SII = platelet count × neutrophil/lymphocyte count. Higher SII scores have been correlated with worse outcome.

    Measured: Preoperatively

  6. Prognostic Nutritional Index (PNI)

    Prognostic Nutritional Index (PNI) is a prognostic index that predicts patients' overall survival. PNI is calculated as follows: PNI = 10 × serum albumin value (g/dL) + 0.005 × total lymphocyte count (per mm3) in the peripheral blood. Higher PNI scores have been correlated with worse outcome.

    Measured: Preoperatively

  7. Surgical Stress Response - IL-6 - preoperatively

    Inflammatory response and stress response as quantified by IL-6 serum levels. Blood sample collection will take place in both study groups

    Measured: Preoperatively (as a baseline)

  8. Surgical Stress Response - IL-6 - end of surgery

    Inflammatory response and stress response as quantified by IL-6 serum levels. Blood sample collection will take place in both study groups

    Measured: End of surgery (end of placement of last suture/ surgical clip on patient)

  9. Surgical Stress Response - IL-6 - 24 hours after the end of surgery

    Inflammatory response and stress response as quantified by IL-6 serum levels. Blood sample collection will take place in both study groups

    Measured: 24 hours after the end of surgery (end of placement of last suture/ surgical clip on patient)

  10. Surgical Stress Response - IL-8 - preoperatively

    Inflammatory response and stress response as quantified by IL-8 serum levels. Blood sample collection will take place in both study groups

    Measured: Preoperatively (as a baseline)

  11. Surgical Stress Response - IL-8 - end of surgery

    Inflammatory response and stress response as quantified by IL-8 serum levels. Blood sample collection will take place in both study groups

    Measured: End of surgery (end of placement of last suture/ surgical clip on patient)

  12. Surgical Stress Response - IL-8 - 24 hours after the end of surgery

    Inflammatory response and stress response as quantified by IL-8 serum levels. Blood sample collection will take place in both study groups

    Measured: 24 hours after the end of surgery (end of placement of last suture/ surgical clip on patient)

  13. Surgical Stress Response - IL-10 - preoperatively

    Inflammatory response and stress response as quantified by IL-10 serum levels. Blood sample collection will take place in both study groups

    Measured: Preoperatively (as a baseline)

  14. Surgical Stress Response - IL-10 - end of surgery

    Inflammatory response and stress response as quantified by IL-10 serum levels. Blood sample collection will take place in both study groups

    Measured: End of surgery (end of placement of last suture/ surgical clip on patient)

  15. Surgical Stress Response - IL-10 - 24 hours after the end of surgery

    Inflammatory response and stress response as quantified by IL-10 serum levels. Blood sample collection will take place in both study groups

    Measured: 24 hours after the end of surgery (end of placement of last suture/ surgical clip on patient)

  16. Surgical Stress Response - TNF-a - preoperatively

    Inflammatory response and stress response as quantified by TNF-a serum levels. Blood sample collection will take place in both study groups

    Measured: Preoperatively (as a baseline)

  17. Surgical Stress Response - TNF-a - end of surgery

    Inflammatory response and stress response as quantified by TNF-a serum levels. Blood sample collection will take place in both study groups

    Measured: End of surgery (end of placement of last suture/ surgical clip on patient)

  18. Surgical Stress Response - TNF-a - 24 hours after the end of surgery

    Inflammatory response and stress response as quantified by TNF-a serum levels. Blood sample collection will take place in both study groups

    Measured: 24 hours after the end of surgery (end of placement of last suture/ surgical clip on patient)

  19. Surgical Stress Response - CRP - preoperatively

    Inflammatory response and stress response as quantified by CRP serum levels. Blood sample collection will take place in both study groups

    Measured: Preoperatively (as a baseline)

  20. Surgical Stress Response - CRP - end of surgery

    Inflammatory response and stress response as quantified by CRP serum levels. Blood sample collection will take place in both study groups

    Measured: End of surgery (end of placement of last suture/ surgical clip on patient)

  21. Surgical Stress Response - CRP - 24 hours after the end of surgery

    Inflammatory response and stress response as quantified by CRP serum levels. Blood sample collection will take place in both study groups

    Measured: 24 hours after the end of surgery (end of placement of last suture/ surgical clip on patient)

  22. Surgical Stress Response - WBC - preoperatively

    Inflammatory response and stress response as quantified by WBC count. Blood sample collection will take place in both study groups

    Measured: Preoperatively (as a baseline)

  23. Surgical Stress Response - WBC - end of surgery

    Inflammatory response and stress response as quantified by WBC count. Blood sample collection will take place in both study groups

    Measured: End of surgery (end of placement of last suture/ surgical clip on patient)

  24. Surgical Stress Response - WBC - 24 hours after the end of surgery

    Inflammatory response and stress response as quantified by WBC count. Blood sample collection will take place in both study groups

    Measured: 24 hours after the end of surgery (end of placement of last suture/ surgical clip on patient)

  25. Surgical Stress Response - AVP - preoperatively

    Inflammatory response and stress response as quantified by AVP serum levels. Blood sample collection will take place in both study groups

    Measured: Preoperatively (as a baseline)

  26. Surgical Stress Response - AVP - end of surgery

    Inflammatory response and stress response as quantified by AVP serum levels. Blood sample collection will take place in both study groups

    Measured: End of surgery (end of placement of last suture/ surgical clip on patient)

  27. Surgical Stress Response - AVP - 24 hours after the end of surgery

    Inflammatory response and stress response as quantified by AVP serum levels. Blood sample collection will take place in both study groups

    Measured: 24 hours after the end of surgery (end of placement of last suture/ surgical clip on patient)

  28. Surgical Stress Response - cortisol - preoperatively

    Inflammatory response and stress response as quantified by cortisol serum levels. Blood sample collection will take place in both study groups

    Measured: Preoperatively (as a baseline)

  29. Surgical Stress Response - cortisol - end of surgery

    Inflammatory response and stress response as quantified by cortisol serum levels. Blood sample collection will take place in both study groups

    Measured: End of surgery (end of placement of last suture/ surgical clip on patient)

  30. Surgical Stress Response - cortisol - 24 hours after the end of surgery

    Inflammatory response and stress response as quantified by cortisol serum levels. Blood sample collection will take place in both study groups

    Measured: 24 hours after the end of surgery (end of placement of last suture/ surgical clip on patient)

  31. Surgical Stress Response - HIF-1α- preoperatively

    Inflammatory response and stress response as quantified by HIF-1α serum levels. Blood sample collection will take place in both study groups

    Measured: Preoperatively (as a baseline)

  32. Surgical Stress Response - HIF-1α - end of surgery

    Inflammatory response and stress response as quantified by HIF-1α serum levels. Blood sample collection will take place in both study groups

    Measured: End of surgery (end of placement of last suture/ surgical clip on patient)

  33. Surgical Stress Response - HIF-1α - 24 hours after the end of surgery

    Inflammatory response and stress response as quantified by HIF-1α serum levels. Blood sample collection will take place in both study groups

    Measured: 24 hours after the end of surgery (end of placement of last suture/ surgical clip on patient)

  34. Surgical Stress Response - VEGF- preoperatively

    Inflammatory response and stress response as quantified by VEGF serum levels. Blood sample collection will take place in both study groups

    Measured: Preoperatively (as a baseline)

  35. Surgical Stress Response - VEGF- end of surgery

    Inflammatory response and stress response as quantified by VEGF serum levels. Blood sample collection will take place in both study groups

    Measured: End of surgery (end of placement of last suture/ surgical clip on patient)

  36. Surgical Stress Response - VEGF - 24 hours after the end of surgery

    Inflammatory response and stress response as quantified by VEGF serum levels. Blood sample collection will take place in both study groups

    Measured: 24 hours after the end of surgery (end of placement of last suture/ surgical clip on patient)

  37. Surgical Stress Response - NF-κB - preoperatively

    Inflammatory response and stress response as quantified by NF-κB serum levels. Blood sample collection will take place in both study groups

    Measured: Preoperatively (as a baseline)

  38. Surgical Stress Response - NF-κB - end of surgery

    Inflammatory response and stress response as quantified by NF-κB serum levels. Blood sample collection will take place in both study groups

    Measured: End of surgery (end of placement of last suture/ surgical clip on patient)

  39. Surgical Stress Response - NF-κB - 24 hours after the end of surgery

    Inflammatory response and stress response as quantified by NF-κB serum levels. Blood sample collection will take place in both study groups

    Measured: 24 hours after the end of surgery (end of placement of last suture/ surgical clip on patient)

  40. Haemodynamic Stability - Mean PR

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Pulse Rate - PR. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Mean PR will be reported for each patient, extracted from the collected data.

    Measured: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]

  41. Haemodynamic Stability - Minimum PR

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Pulse Rate - PR. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Minimum PR will be reported for each patient, extracted from the collected data.

    Measured: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]

  42. Haemodynamic Stability - Maximum PR

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Pulse Rate - PR. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Maximum PR will be reported for each patient, extracted from the collected data.

    Measured: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]

  43. Haemodynamic Stability - Standard Deviation PR

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Pulse Rate - PR. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Standard Deviation PR will be reported for each patient, extracted from the collected data.

    Measured: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]

  44. Haemodynamic Stability - PR Change Induction

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Pulse Rate change 1 minute after anesthesia induction, compared to 1 minute prior. Data will be collected from a pulse contour analysis monitor.

    Measured: 1 minute after anesthesia induction, compared to 1 minute prior

  45. Haemodynamic Stability - PR Change Incision

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Pulse Rate change 1 minute after surgical incision, compared to 1 minute prior. Data will be collected from a pulse contour analysis monitor.

    Measured: 1 minute after surgical incision, compared to 1 minute prior

  46. Haemodynamic Stability - Mean SBP

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Systolic Blood Pressure - SBP. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Mean SBP will be reported for each patient, extracted from the collected data.

    Measured: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]

  47. Haemodynamic Stability - Minimum SBP

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Systolic Blood Pressure - SBP. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Minimum SBP will be reported for each patient, extracted from the collected data.

    Measured: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]

  48. Haemodynamic Stability - Maximum SBP

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Systolic Blood Pressure - SBP. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Maximum SBP will be reported for each patient, extracted from the collected data.

    Measured: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]

  49. Haemodynamic Stability - Standard Deviation SBP

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Systolic Blood Pressure - SBP. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Standard Deviation SBP will be reported for each patient, extracted from the collected data.

    Measured: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]

  50. Haemodynamic Stability - SBP Change Induction

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Systolic Blood Pressure change 1 minute after anesthesia induction, compared to 1 minute prior. Data will be collected from a pulse contour analysis monitor.

    Measured: 1 minute after anesthesia induction, compared to 1 minute prior

  51. Haemodynamic Stability - SBP Change Incision

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Systolic Blood Pressure change 1 minute after surgical incision, compared to 1 minute prior. Data will be collected from a pulse contour analysis monitor.

    Measured: 1 minute after surgical incision, compared to 1 minute prior

  52. Haemodynamic Stability - Mean DBP

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Diastolic Blood Pressure - DBP. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Mean DBP will be reported for each patient, extracted from the collected data.

    Measured: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]

  53. Haemodynamic Stability - Minimum DBP

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Diastolic Blood Pressure - DBP. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Minimum DBP will be reported for each patient, extracted from the collected data.

    Measured: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]

  54. Haemodynamic Stability - Maximum DBP

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Diastolic Blood Pressure - DBP. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Maximum DBP will be reported for each patient, extracted from the collected data.

    Measured: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]

  55. Haemodynamic Stability - Standard Deviation DBP

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Diastolic Blood Pressure - DBP. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Standard Deviation DBP will be reported for each patient, extracted from the collected data.

    Measured: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]

  56. Haemodynamic Stability - DBP change induction

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Diastolic Blood Pressure change 1 minute after anesthesia induction, compared to 1 minute prior. Data will be collected from a pulse contour analysis monitor.

    Measured: 1 minute after anesthesia induction, compared to 1 minute prior

  57. Haemodynamic Stability - DBP change incision

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Diastolic Blood Pressure change 1 minute after surgical incision, compared to 1 minute prior. Data will be collected from a pulse contour analysis monitor.

    Measured: 1 minute after surgical incision, compared to 1 minute prior

  58. Haemodynamic Stability - Mean MBP

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Mean Blood Pressure - MBP. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Mean MBP will be reported for each patient, extracted from the collected data.

    Measured: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]

  59. Haemodynamic Stability - Minimum MBP

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Mean Blood Pressure - MBP. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Minimum MBP will be reported for each patient, extracted from the collected data.

    Measured: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]

  60. Haemodynamic Stability - Maximum MBP

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Mean Blood Pressure - MBP. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Maximum MBP will be reported for each patient, extracted from the collected data.

    Measured: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]

  61. Haemodynamic Stability - Standard Deviation MBP

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Mean Blood Pressure - MBP. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Standard Deviation MBP will be reported for each patient, extracted from the collected data.

    Measured: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]

  62. Haemodynamic Stability - MBP change induction

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Mean Blood Pressure change 1 minute after anesthesia induction, compared to 1 minute prior. Data will be collected from a pulse contour analysis monitor.

    Measured: 1 minute after anesthesia induction, compared to 1 minute prior

  63. Haemodynamic Stability - MBP change incision

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Mean Blood Pressure change 1 minute after surgical incision, compared to 1 minute prior. Data will be collected from a pulse contour analysis monitor.

    Measured: 1 minute after surgical incision, compared to 1 minute prior

  64. Haemodynamic Stability - Mean CO

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Cardiac Output - CO. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Mean CO will be reported for each patient, extracted from the collected data.

    Measured: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]

  65. Haemodynamic Stability - Minimum CO

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Cardiac Output - CO. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Minimum CO will be reported for each patient, extracted from the collected data.

    Measured: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]

  66. Haemodynamic Stability - Maximum CO

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Cardiac Output - CO. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Maximum CO will be reported for each patient, extracted from the collected data.

    Measured: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]

  67. Haemodynamic Stability - Standard Deviation CO

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Cardiac Output - CO. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Standard Deviation CO will be reported for each patient, extracted from the collected data.

    Measured: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]

  68. Haemodynamic Stability - Mean CI

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Cardiac Index - CI. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Mean CI will be reported for each patient, extracted from the collected data.

    Measured: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]

  69. Haemodynamic Stability - Minimum CI

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Cardiac Index - CI. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Minimum CI will be reported for each patient, extracted from the collected data.

    Measured: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]

  70. Haemodynamic Stability - Maximum CI

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Cardiac Index - CI. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Maximum CI will be reported for each patient, extracted from the collected data.

    Measured: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]

  71. Haemodynamic Stability - Standard Deviation CI

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Cardiac Index - CI. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Standard Deviation CI will be reported for each patient, extracted from the collected data.

    Measured: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]

  72. Haemodynamic Stability - Mean SV

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Stroke Volume - SV. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Mean SV will be reported for each patient, extracted from the collected data.

    Measured: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]

  73. Haemodynamic Stability - Minimum SV

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Stroke Volume - SV. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Minimum SV will be reported for each patient, extracted from the collected data.

    Measured: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]

  74. Haemodynamic Stability - Maximum SV

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Stroke Volume - SV. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Maximum SV will be reported for each patient, extracted from the collected data.

    Measured: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]

  75. Haemodynamic Stability - Standard Deviation SV

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Stroke Volume - SV. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Standard Deviation SV will be reported for each patient, extracted from the collected data.

    Measured: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]

  76. Haemodynamic Stability - Mean SVV

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Stroke Volume Variation - SVV. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Mean SVV will be reported for each patient, extracted from the collected data.

    Measured: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]

  77. Haemodynamic Stability - Minimum SVV

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Stroke Volume Variation - SVV. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Minimum SVV will be reported for each patient, extracted from the collected data.

    Measured: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]

  78. Haemodynamic Stability - Maximum SVV

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Stroke Volume Variation - SVV. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Maximum SVV will be reported for each patient, extracted from the collected data.

    Measured: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]

  79. Haemodynamic Stability - Standard Deviation SVV

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Stroke Volume Variation - SVV. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Standard Deviation SVV will be reported for each patient, extracted from the collected data.

    Measured: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]

  80. Haemodynamic Stability - Mean SVI

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Stroke Volume Index - SVI. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Mean SVI will be reported for each patient, extracted from the collected data.

    Measured: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]

  81. Haemodynamic Stability - Minimum SVI

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Stroke Volume Index - SVI. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Minimum SVI will be reported for each patient, extracted from the collected data.

    Measured: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]

  82. Haemodynamic Stability - Maximum SVI

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Stroke Volume Index - SVI. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Maximum SVI will be reported for each patient, extracted from the collected data.

    Measured: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]

  83. Haemodynamic Stability - Standard Deviation SVI

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Stroke Volume Index - SVI. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Standard Deviation SVI will be reported for each patient, extracted from the collected data.

    Measured: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]

  84. Haemodynamic Stability - Tachycardia

    Intraoperative Tachycardia (defined as PR≥ 100 bpm), with episodes lasting ≥1 minute. Data will be reported in total seconds of intraoperative tachycardia.

    Measured: Intraoperatively, assessed up to 4 hours.

  85. Haemodynamic Stability - Bradycardia

    Intraoperative Bradycardia (defined as PR≤ 60 bpm), with episodes lasting ≥1 minute. Data will be reported in total seconds of intraoperative bradycardia.

    Measured: Intraoperatively, assessed up to 4 hours.

  86. Haemodynamic Stability - Hypotension

    Intraoperative Hypotension (defined as SBP≤100mmHg or ≤70% of preoperative Baseline), with episodes lasting ≥1 minute. All patients will have a 5 minute preoperative SBP baseline, with measurements every 20 seconds. Intraoperative data will be compared to the mean preoperative 5 minute SPB baseline. Data will be reported in total seconds of intraoperative hypotension.

    Measured: Intraoperatively, assessed up to 6 hours.

  87. Haemodynamic Stability - Hypertension

    Intraoperative Hypertension (defined as SBP ≥130% of preoperative Baseline), with episodes lasting ≥1 minute. All patients will have a 5 minute preoperative SBP baseline, with measurements every 20 seconds. Intraoperative data will be compared to the mean preoperative 5 minute SPB baseline. Data will be reported in total seconds of intraoperative hypertension.

    Measured: Intraoperatively, assessed up to 6 hours.

  88. Haemodynamic Stability - Fluid requirements - Crystalloids - Intraoperatively

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Crystalloid Fluid Requirements.

    Measured: Intraoperatively, assessed up to 6 hours.

  89. Haemodynamic Stability - Fluid requirements - Colloids - Intraoperatively

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Colloid Fluid Requirements.

    Measured: Intraoperatively, assessed up to 6 hours.

  90. Haemodynamic Stability - Fluid requirements - Concentrated RBCs - Intraoperatively

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Concentrated Red Blood Cell unit Requirements.

    Measured: Intraoperatively, assessed up to 6 hours.

  91. Haemodynamic Stability - Fluid requirements - Plasma - Intraoperatively

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Plasma unit Requirements.

    Measured: Intraoperatively, assessed up to 6 hours.

  92. Haemodynamic Stability - Fluid requirements - Platelets - Intraoperatively

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Platelet unit Requirements.

    Measured: Intraoperatively, assessed up to 6 hours.

  93. Haemodynamic Stability - Blood Loss - Intraoperatively

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Blood Loss

    Measured: Intraoperatively, assessed up to 6 hours.

  94. Haemodynamic Stability - Fluid Balance - Intraoperatively

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Fluid Balance

    Measured: Intraoperatively, assessed up to 6 hours.

  95. Haemodynamic Stability - Vasoactive Requirements - Adrenaline - Intraoperatively

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Adrenaline requirements

    Measured: Intraoperatively, assessed up to 6 hours.

  96. Haemodynamic Stability - Vasoactive Requirements - Noradrenaline - Intraoperatively

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Noradrenaline requirements

    Measured: Intraoperatively, assessed up to 6 hours.

  97. Haemodynamic Stability - Vasoactive Requirements - Ephedrine - Intraoperatively

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Ephedrine requirements

    Measured: Intraoperatively, assessed up to 6 hours.

  98. Haemodynamic Stability - Vasoactive Requirements - Phenylephrine - Intraoperatively

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Phenylephrine requirements

    Measured: Intraoperatively, assessed up to 6 hours.

  99. Haemodynamic Stability - Vasoactive Requirements - Dopamine - Intraoperatively

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Dopamine requirements

    Measured: Intraoperatively, assessed up to 6 hours.

  100. Haemodynamic Stability - Vasoactive Requirements - Dobutamine - Intraoperatively

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Dobutamine requirements

    Measured: Intraoperatively, assessed up to 6 hours.

  101. Haemodynamic Stability - Vasoactive Requirements - Nitroglycerine - Intraoperatively

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Nitroglycerine requirements

    Measured: Intraoperatively, assessed up to 6 hours.

Secondary outcomes (77)

  1. Acute postoperative pain - Numerical Rating Scale (NRS) - Immediately Postoperatively

    Evaluation of patients' pain using scales: Numerical Rating Scale (NRS). The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").

    Measured: Immediately postoperatively

  2. Acute postoperative pain - Numerical Rating Scale (NRS) - First postoperative day

    Evaluation of patients' pain using scales: Numerical Rating Scale (NRS). The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").

    Measured: First postoperative day

  3. Acute postoperative pain - Numerical Rating Scale (NRS) - Second postoperative day

    Evaluation of patients' pain using scales: Numerical Rating Scale (NRS). The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").

    Measured: Second postoperative day

  4. Acute postoperative pain - Numerical Rating Scale (NRS) - Third postoperative day

    Evaluation of patients' pain using scales: Numerical Rating Scale (NRS). The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").

    Measured: Third postoperative day

  5. Acute postoperative pain - Critical Care Pain Observation Tool (CPOT) - Immediately Postoperatively

    Evaluation of patients' pain using scales: Critical Care Pain Observation Tool (CPOT). The scale consists of four behavioral domains: facial expression, body movements, muscle tension and compliance with the ventilation for intubated patients or vocalization for extubated patients. Patient's behavior in each domain is scored between 0 and 2. The possible total score ranges from 0 (no pain) to 8 (maximum pain).

    Measured: Immediately postoperatively

  6. Acute postoperative pain - Critical Care Pain Observation Tool (CPOT) - First postoperative day

    Evaluation of patients' pain using scales: Critical Care Pain Observation Tool (CPOT). The scale consists of four behavioral domains: facial expression, body movements, muscle tension and compliance with the ventilation for intubated patients or vocalization for extubated patients. Patient's behavior in each domain is scored between 0 and 2. The possible total score ranges from 0 (no pain) to 8 (maximum pain).

    Measured: First postoperative day

  7. Acute postoperative pain - Critical Care Pain Observation Tool (CPOT) - Second postoperative day

    Evaluation of patients' pain using scales: Critical Care Pain Observation Tool (CPOT). The scale consists of four behavioral domains: facial expression, body movements, muscle tension and compliance with the ventilation for intubated patients or vocalization for extubated patients. Patient's behavior in each domain is scored between 0 and 2. The possible total score ranges from 0 (no pain) to 8 (maximum pain).

    Measured: Second postoperative day

  8. Acute postoperative pain - Critical Care Pain Observation Tool (CPOT) - Third postoperative day

    Evaluation of patients' pain using scales: Critical Care Pain Observation Tool (CPOT). The scale consists of four behavioral domains: facial expression, body movements, muscle tension and compliance with the ventilation for intubated patients or vocalization for extubated patients. Patient's behavior in each domain is scored between 0 and 2. The possible total score ranges from 0 (no pain) to 8 (maximum pain).

    Measured: Third postoperative day

  9. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Intolerable - First postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to how comfortable patients feel with their pain, available answers will be:

    1. Intolerable
    2. Tolerable with discomfort
    3. Comfortably manageable
    4. Negligible Pain

    The percentage of patients that report pain that is "Intolerable" will be reported

    Measured: First postoperative day

  10. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Intolerable - Second postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to how comfortable patients feel with their pain, available answers will be:

    1. Intolerable
    2. Tolerable with discomfort
    3. Comfortably manageable
    4. Negligible Pain

    The percentage of patients that report pain that is "Intolerable" will be reported

    Measured: Second postoperative day

  11. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Intolerable - Third postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to how comfortable patients feel with their pain, available answers will be:

    1. Intolerable
    2. Tolerable with discomfort
    3. Comfortably manageable
    4. Negligible Pain

    The percentage of patients that report pain that is "Intolerable" will be reported

    Measured: Third postoperative day

  12. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Tolerable with discomfort - First postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to how comfortable patients feel with their pain, available answers will be:

    1. Intolerable
    2. Tolerable with discomfort
    3. Comfortably manageable
    4. Negligible Pain

    The percentage of patients that report pain that is "Tolerable with Discomfort" will be reported

    Measured: First postoperative day

  13. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Tolerable with discomfort - Second postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to how comfortable patients feel with their pain, available answers will be:

    1. Intolerable
    2. Tolerable with discomfort
    3. Comfortably manageable
    4. Negligible Pain

    The percentage of patients that report pain that is "Tolerable with Discomfort" will be reported

    Measured: Second postoperative day

  14. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Tolerable with discomfort - Third postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to how comfortable patients feel with their pain, available answers will be:

    1. Intolerable
    2. Tolerable with discomfort
    3. Comfortably manageable
    4. Negligible Pain

    The percentage of patients that report pain that is "Tolerable with Discomfort" will be reported

    Measured: Third postoperative day

  15. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Comfortably manageable - First postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to how comfortable patients feel with their pain, available answers will be:

    1. Intolerable
    2. Tolerable with discomfort
    3. Comfortably manageable
    4. Negligible Pain

    The percentage of patients that report pain that is "Comfortably manageable" will be reported

    Measured: First postoperative day

  16. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Comfortably manageable - Second postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to how comfortable patients feel with their pain, available answers will be:

    1. Intolerable
    2. Tolerable with discomfort
    3. Comfortably manageable
    4. Negligible Pain

    The percentage of patients that report pain that is "Comfortably manageable" will be reported

    Measured: Second postoperative day

  17. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Comfortably manageable - Third postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to how comfortable patients feel with their pain, available answers will be:

    1. Intolerable
    2. Tolerable with discomfort
    3. Comfortably manageable
    4. Negligible Pain

    The percentage of patients that report pain that is "Comfortably manageable" will be reported

    Measured: Third postoperative day

  18. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Negligible Pain - First postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to how comfortable patients feel with their pain, available answers will be:

    1. Intolerable
    2. Tolerable with discomfort
    3. Comfortably manageable
    4. Negligible Pain

    The percentage of patients that report pain that is "Negligible Pain" will be reported

    Measured: First postoperative day

  19. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Negligible Pain - Second postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to how comfortable patients feel with their pain, available answers will be:

    1. Intolerable
    2. Tolerable with discomfort
    3. Comfortably manageable
    4. Negligible Pain

    The percentage of patients that report pain that is "Negligible Pain" will be reported

    Measured: Second postoperative day

  20. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Negligible Pain - Third postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to how comfortable patients feel with their pain, available answers will be:

    1. Intolerable
    2. Tolerable with discomfort
    3. Comfortably manageable
    4. Negligible Pain

    The percentage of patients that report pain that is "Negligible Pain" will be reported

    Measured: Third postoperative day

  21. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - Getting Worse - First postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to changes in pain perception by patients, available answers will be:

    1. Getting worse
    2. About the same
    3. Getting better

    The percentage of patients that report pain that is "Getting worse" will be reported

    Measured: First postoperative day

  22. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - Getting Worse - Second postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to changes in pain perception by patients, available answers will be:

    1. Getting worse
    2. About the same
    3. Getting better

    The percentage of patients that report pain that is "Getting worse" will be reported

    Measured: Second postoperative day

  23. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - Getting Worse - Third postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to changes in pain perception by patients, available answers will be:

    1. Getting worse
    2. About the same
    3. Getting better

    The percentage of patients that report pain that is "Getting worse" will be reported

    Measured: Third postoperative day

  24. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - About the same - First postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to changes in pain perception by patients, available answers will be:

    1. Getting worse
    2. About the same
    3. Getting better

    The percentage of patients that report pain that is "About the same" will be reported

    Measured: First postoperative day

  25. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - About the same - Second postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to changes in pain perception by patients, available answers will be:

    1. Getting worse
    2. About the same
    3. Getting better

    The percentage of patients that report pain that is "About the same" will be reported

    Measured: Second postoperative day

  26. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - About the same - Third postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to changes in pain perception by patients, available answers will be:

    1. Getting worse
    2. About the same
    3. Getting better

    The percentage of patients that report pain that is "About the same" will be reported

    Measured: Third postoperative day

  27. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - Getting better - First postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to changes in pain perception by patients, available answers will be:

    1. Getting worse
    2. About the same
    3. Getting better

    The percentage of patients that report pain that is "Getting Better" will be reported

    Measured: First postoperative day

  28. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - Getting better - Second postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to changes in pain perception by patients, available answers will be:

    1. Getting worse
    2. About the same
    3. Getting better

    The percentage of patients that report pain that is "Getting Better" will be reported

    Measured: Second postoperative day

  29. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - Getting better - Third postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to changes in pain perception by patients, available answers will be:

    1. Getting worse
    2. About the same
    3. Getting better

    The percentage of patients that report pain that is "Getting Better" will be reported

    Measured: Third postoperative day

  30. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Inadequate pain control - First postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to pain control reported by patients, available answers will be:

    1. Inadequate pain control
    2. Effective, just about right
    3. Would like to reduce medication

    The percentage of patients that report "Inadequate pain control" will be reported

    Measured: First postoperative day

  31. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Inadequate pain control - Second postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to pain control reported by patients, available answers will be:

    1. Inadequate pain control
    2. Effective, just about right
    3. Would like to reduce medication

    The percentage of patients that report "Inadequate pain control" will be reported

    Measured: Second postoperative day

  32. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Inadequate pain control - Third postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to pain control reported by patients, available answers will be:

    1. Inadequate pain control
    2. Effective, just about right
    3. Would like to reduce medication

    The percentage of patients that report "Inadequate pain control" will be reported

    Measured: Third postoperative day

  33. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Effective, just about right - First postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to pain control reported by patients, available answers will be:

    1. Inadequate pain control
    2. Effective, just about right
    3. Would like to reduce medication

    The percentage of patients that report "Effective, just about right" will be reported

    Measured: First postoperative day

  34. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Effective, just about right - Second postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to pain control reported by patients, available answers will be:

    1. Inadequate pain control
    2. Effective, just about right
    3. Would like to reduce medication

    The percentage of patients that report "Effective, just about right" will be reported

    Measured: Second postoperative day

  35. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Effective, just about right - Third postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to pain control reported by patients, available answers will be:

    1. Inadequate pain control
    2. Effective, just about right
    3. Would like to reduce medication

    The percentage of patients that report "Effective, just about right" will be reported

    Measured: Third postoperative day

  36. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Would like to reduce medication - First postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to pain control reported by patients, available answers will be:

    1. Inadequate pain control
    2. Effective, just about right
    3. Would like to reduce medication

    The percentage of patients that report "Would like to reduce medication" will be reported

    Measured: First postoperative day

  37. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Would like to reduce medication - Second postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to pain control reported by patients, available answers will be:

    1. Inadequate pain control
    2. Effective, just about right
    3. Would like to reduce medication

    The percentage of patients that report "Would like to reduce medication" will be reported

    Measured: Second postoperative day

  38. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Would like to reduce medication - Third postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to pain control reported by patients, available answers will be:

    1. Inadequate pain control
    2. Effective, just about right
    3. Would like to reduce medication

    The percentage of patients that report "Would like to reduce medication" will be reported

    Measured: Third postoperative day

  39. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Can't do anything because of pain - First postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to functioning - for the usual things patients need to do, available answers will be:

    1. Can't do anything because of pain
    2. Pain keeps me from doing most of what I need to do
    3. Can do most things, but pain gets in the way of some
    4. Can do everything I need to do

    The percentage of patients whose functioning is reported as "Can't do anything because of pain" will be reported

    Measured: First postoperative day

  40. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Can't do anything because of pain - Second postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to functioning - for the usual things patients need to do, available answers will be:

    1. Can't do anything because of pain
    2. Pain keeps me from doing most of what I need to do
    3. Can do most things, but pain gets in the way of some
    4. Can do everything I need to do

    The percentage of patients whose functioning is reported as "Can't do anything because of pain" will be reported

    Measured: Second postoperative day

  41. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Can't do anything because of pain - Third postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to functioning - for the usual things patients need to do, available answers will be:

    1. Can't do anything because of pain
    2. Pain keeps me from doing most of what I need to do
    3. Can do most things, but pain gets in the way of some
    4. Can do everything I need to do

    The percentage of patients whose functioning is reported as "Can't do anything because of pain" will be reported

    Measured: Third postoperative day

  42. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Pain keeps me from doing most of what I need to do - First postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to functioning - for the usual things patients need to do, available answers will be:

    1. Can't do anything because of pain
    2. Pain keeps me from doing most of what I need to do
    3. Can do most things, but pain gets in the way of some
    4. Can do everything I need to do

    The percentage of patients whose functioning is reported as "Pain keeps me from doing most of what I need to do" will be reported

    Measured: First postoperative day

  43. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Pain keeps me from doing most of what I need to do - Second postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to functioning - for the usual things patients need to do, available answers will be:

    1. Can't do anything because of pain
    2. Pain keeps me from doing most of what I need to do
    3. Can do most things, but pain gets in the way of some
    4. Can do everything I need to do

    The percentage of patients whose functioning is reported as "Pain keeps me from doing most of what I need to do" will be reported

    Measured: Second postoperative day

  44. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Pain keeps me from doing most of what I need to do - Third postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to functioning - for the usual things patients need to do, available answers will be:

    1. Can't do anything because of pain
    2. Pain keeps me from doing most of what I need to do
    3. Can do most things, but pain gets in the way of some
    4. Can do everything I need to do

    The percentage of patients whose functioning is reported as "Pain keeps me from doing most of what I need to do" will be reported

    Measured: Third postoperative day

  45. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Can do most things, but pain gets in the way of some - First postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to functioning - for the usual things patients need to do, available answers will be:

    1. Can't do anything because of pain
    2. Pain keeps me from doing most of what I need to do
    3. Can do most things, but pain gets in the way of some
    4. Can do everything I need to do

    The percentage of patients whose functioning is reported as "Can do most things, but pain gets in the way of some" will be reported

    Measured: First postoperative day

  46. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Can do most things, but pain gets in the way of some - Second postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to functioning - for the usual things patients need to do, available answers will be:

    1. Can't do anything because of pain
    2. Pain keeps me from doing most of what I need to do
    3. Can do most things, but pain gets in the way of some
    4. Can do everything I need to do

    The percentage of patients whose functioning is reported as "Can do most things, but pain gets in the way of some" will be reported

    Measured: Second postoperative day

  47. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Can do most things, but pain gets in the way of some - Third postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to functioning - for the usual things patients need to do, available answers will be:

    1. Can't do anything because of pain
    2. Pain keeps me from doing most of what I need to do
    3. Can do most things, but pain gets in the way of some
    4. Can do everything I need to do

    The percentage of patients whose functioning is reported as "Can do most things, but pain gets in the way of some" will be reported

    Measured: Third postoperative day

  48. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Can do everything I need to do - First postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to functioning - for the usual things patients need to do, available answers will be:

    1. Can't do anything because of pain
    2. Pain keeps me from doing most of what I need to do
    3. Can do most things, but pain gets in the way of some
    4. Can do everything I need to do

    The percentage of patients whose functioning is reported as "Can do everything I need to do" will be reported

    Measured: First postoperative day

  49. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Can do everything I need to do - Second postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to functioning - for the usual things patients need to do, available answers will be:

    1. Can't do anything because of pain
    2. Pain keeps me from doing most of what I need to do
    3. Can do most things, but pain gets in the way of some
    4. Can do everything I need to do

    The percentage of patients whose functioning is reported as "Can do everything I need to do" will be reported

    Measured: Second postoperative day

  50. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Can do everything I need to do - Third postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to functioning - for the usual things patients need to do, available answers will be:

    1. Can't do anything because of pain
    2. Pain keeps me from doing most of what I need to do
    3. Can do most things, but pain gets in the way of some
    4. Can do everything I need to do

    The percentage of patients whose functioning is reported as "Can do everything I need to do" will be reported

    Measured: Third postoperative day

  51. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Sleep - Awake with pain most of the night - First postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to sleep, if the pain is waking patients up, available answers will be:

    1. Awake with pain most of the night
    2. Awake with occasional pain
    3. Normal sleep

    The percentage of patients whose sleep is reported as "Awake with pain most of the night" will be reported

    Measured: First postoperative day

  52. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Sleep - Awake with pain most of the night - Second postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to sleep, if the pain is waking patients up, available answers will be:

    1. Awake with pain most of the night
    2. Awake with occasional pain
    3. Normal sleep

    The percentage of patients whose sleep is reported as "Awake with pain most of the night" will be reported

    Measured: Second postoperative day

  53. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Sleep - Awake with pain most of the night - Third postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to sleep, if the pain is waking patients up, available answers will be:

    1. Awake with pain most of the night
    2. Awake with occasional pain
    3. Normal sleep

    The percentage of patients whose sleep is reported as "Awake with pain most of the night" will be reported

    Measured: Third postoperative day

  54. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Sleep - Awake with occasional pain - First postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to sleep, if the pain is waking patients up, available answers will be:

    1. Awake with pain most of the night
    2. Awake with occasional pain
    3. Normal sleep

    The percentage of patients whose sleep is reported as " Awake with occasional pain" will be reported

    Measured: First postoperative day

  55. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Sleep - Awake with occasional pain - Second postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to sleep, if the pain is waking patients up, available answers will be:

    1. Awake with pain most of the night
    2. Awake with occasional pain
    3. Normal sleep

    The percentage of patients whose sleep is reported as " Awake with occasional pain" will be reported

    Measured: Second postoperative day

  56. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Sleep - Awake with occasional pain - Third postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to sleep, if the pain is waking patients up, available answers will be:

    1. Awake with pain most of the night
    2. Awake with occasional pain
    3. Normal sleep

    The percentage of patients whose sleep is reported as " Awake with occasional pain" will be reported

    Measured: Third postoperative day

  57. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Sleep - Normal sleep - First postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to sleep, if the pain is waking patients up, available answers will be:

    1. Awake with pain most of the night
    2. Awake with occasional pain
    3. Normal sleep

    The percentage of patients whose sleep is reported as "Normal sleep" will be reported

    Measured: First postoperative day

  58. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Sleep - Normal sleep - Second postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to sleep, if the pain is waking patients up, available answers will be:

    1. Awake with pain most of the night
    2. Awake with occasional pain
    3. Normal sleep

    The percentage of patients whose sleep is reported as "Normal sleep" will be reported

    Measured: Second postoperative day

  59. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Sleep - Normal sleep - Third postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to sleep, if the pain is waking patients up, available answers will be:

    1. Awake with pain most of the night
    2. Awake with occasional pain
    3. Normal sleep

    The percentage of patients whose sleep is reported as "Normal sleep" will be reported

    Measured: Third postoperative day

  60. Analgesic Requirements - First postoperative day

    Evaluation of patients' pain by recording the number of times that rescue analgesia (tramadol) was required.

    Measured: First postoperative day

  61. Analgesic Requirements - Second postoperative day

    Evaluation of patients' pain by recording the number of times that rescue analgesia (tramadol) was required.

    Measured: Second postoperative day

  62. Analgesic Requirements - Third postoperative day

    Evaluation of patients' pain by recording the number of times that rescue analgesia (tramadol) was required.

    Measured: Third postoperative day

  63. Postoperative Pulmonary Complications - Aspiration Pneumonitis

    Aspiration pneumonitis (defined as respiratory failure after the inhalation of regurgitated gastric contents)

    Measured: From the first postoperative day, until the fifth postoperative day

  64. Postoperative Pulmonary Complications - Moderate respiratory failure

    Moderate respiratory failure (SpO2 < 90% or PaO2 < 60 mmHg for 10 min in room air, responding to oxygen > 2 L/min)

    Measured: From the first postoperative day, until the fifth postoperative day

  65. Postoperative Pulmonary Complications - Severe respiratory failure

    Severe respiratory failure (need for non-invasive or invasive mechanical ventilation due to poor oxygenation)

    Measured: From the first postoperative day, until the fifth postoperative day

  66. Postoperative Pulmonary Complications - ARDS

    Adult respiratory distress syndrome (mild, moderate, or severe according to the Berlin definition)

    Measured: From the first postoperative day, until the fifth postoperative day

  67. Postoperative Pulmonary Complications - Pulmonary Infection

    Pulmonary infection (defined as new or progressive radiographic infiltrate plus at least two of the following: antibiotic treatment, tympanic temperature > 38 °C, leukocytosis or leucopenia (white blood cell (WBC) count < 4000 cells/mm3 or > 12,000 cells/mm3) and/or purulent secretions)

    Measured: From the first postoperative day, until the fifth postoperative day

  68. Postoperative Pulmonary Complications - Atelectasis

    Atelectasis (suggested by lung opacification with shift of the mediastinum, hilum, or hemidiaphragm towards the affected area, and compensatory over-inflation in the adjacent non-atelectatic lung)

    Measured: From the first postoperative day, until the fifth postoperative day

  69. Postoperative Pulmonary Complications - Cardiopulmonary edema

    Cardiopulmonary edema (defined as clinical signs of congestion, including dyspnea, edema, rales, and jugular venous distention, with the chest x-ray demonstrating increase in vascular markings and diffuse alveolar interstitial infiltrates)

    Measured: From the first postoperative day, until the fifth postoperative day

  70. Postoperative Pulmonary Complications - Pleural effusion

    Pleural effusion (chest x-ray demonstrating blunting of the costophrenic angle, loss of the sharp silhouette of the ipsilateral hemidiaphragm in upright position, evidence of displacement of adjacent anatomical structures, or (in supine position) a hazy opacity in one hemithorax with preserved vascular shadows)

    Measured: From the first postoperative day, until the fifth postoperative day

  71. Postoperative Pulmonary Complications - Pneumothorax

    Pneumothorax (defined as air in the pleural space with no vascular bed surrounding the visceral pleura)

    Measured: From the first postoperative day, until the fifth postoperative day

  72. Postoperative Pulmonary Complications - Pulmonary Infiltrates

    Pulmonary infiltrates (chest x-ray demonstrating new monolateral or bilateral infiltrate without other clinical signs)

    Measured: From the first postoperative day, until the fifth postoperative day

  73. Postoperative Pulmonary Complications - Prolonged air leakage

    Prolonged air leakage (air leak requiring at least 7 days of postoperative chest tube drainage)

    Measured: From the first postoperative day, until the fifth postoperative day

  74. Postoperative Pulmonary Complications - Purulent pleuritic

    Purulent pleuritic (receiving antibiotics for a suspected infection, as far as not explained by the preoperative patient condition alone)

    Measured: From the first postoperative day, until the fifth postoperative day

  75. Postoperative Pulmonary Complications - Pulmonary embolism

    Pulmonary embolism (as documented by pulmonary arteriogram or autopsy, or supported by ventilation/perfusion radioisotope scans, or documented by echocardiography and receiving specific therapy)

    Measured: From the first postoperative day, until the fifth postoperative day

  76. Postoperative Pulmonary Complications - Lung hemorrhage

    Lung hemorrhage (bleeding through the chest tubes requiring reoperation, or three or more red blood cell packs)

    Measured: From the first postoperative day, until the fifth postoperative day

  77. Chronic postoperative pain - Pain Detect

    Evaluation of patients' pain using the standardized "Pain Detect" questionnaire. The "Pain Detect" questionnaire has been standardized for screening the presence of a neuropathic pain component. Patients will be interviewed by phone interview, 3 months after the end of surgery. The possible score a patient can have, ranges from 0 to 38.

    Measured: Three months after the end of surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Dec 2021
  2. Study start1 Oct 2021
  3. Primary completion1 Nov 2025 (estimated)
  4. Study completion1 Nov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Model description
Administration of a multimodal anaesthetic opioid-free strategy that includes pregabalin, ketamine, dexmedetomidine, lidocaine, dexamethasone, magnesium sulphate, paracetamol and dexketoprofen is expected to affect the inflammatory and stress response, measured by levels of inflammatory markers and haemodynamic stability, when compared to conventional opioid based techniques. An Opioid-Free Anaesthesia-Analgesia strategy, is expected to also lead to an attenuated immunosuppression, due to the avoidance of opioids, whose administration has been corelated with immunosuppressive effects. An overall decreased inflammatory and stress response as expressed by reduced levels of inflammatory biomarkers and hemodynamic stability, is expected to decrease peripheral and central sensitization, contributing to better postoperative analgesia.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05172739
Sponsor's protocol ID
OFA-Thoracic
Status last verified
Dec 2021
First submitted
13 Nov 2021
Last updated
29 Dec 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sanchez-Pedrosa G, Vara Ameigeiras E, Casanova Barea J, Rancan L, Simon Adiego CM, Garutti Martinez I. Role of surgical manipulation in lung inflammatory response in a model of lung resection surgery. Interact Cardiovasc Thorac Surg. 2018 Dec 1;27(6):870-877. doi: 10.1093/icvts/ivy198.

    PubMed 29945217

  • Schneemilch CE, Hachenberg T, Ansorge S, Ittenson A, Bank U. Effects of different anaesthetic agents on immune cell function in vitro. Eur J Anaesthesiol. 2005 Aug;22(8):616-23. doi: 10.1017/s0265021505001031.

    PubMed 16119599

  • Homburger JA, Meiler SE. Anesthesia drugs, immunity, and long-term outcome. Curr Opin Anaesthesiol. 2006 Aug;19(4):423-8. doi: 10.1097/01.aco.0000236143.61593.14.

    PubMed 16829725

  • Kurosawa S, Kato M. Anesthetics, immune cells, and immune responses. J Anesth. 2008;22(3):263-77. doi: 10.1007/s00540-008-0626-2. Epub 2008 Aug 7.

    PubMed 18685933

  • Calogero AE, Norton JA, Sheppard BC, Listwak SJ, Cromack DT, Wall R, Jensen RT, Chrousos GP. Pulsatile activation of the hypothalamic-pituitary-adrenal axis during major surgery. Metabolism. 1992 Aug;41(8):839-45. doi: 10.1016/0026-0495(92)90164-6.

    PubMed 1640860

  • Ninkovic J, Roy S. Role of the mu-opioid receptor in opioid modulation of immune function. Amino Acids. 2013 Jul;45(1):9-24. doi: 10.1007/s00726-011-1163-0. Epub 2011 Dec 15.

    PubMed 22170499

  • Kosciuczuk U, Knapp P, Lotowska-Cwiklewska AM. Opioid-induced immunosuppression and carcinogenesis promotion theories create the newest trend in acute and chronic pain pharmacotherapy. Clinics (Sao Paulo). 2020 Mar 23;75:e1554. doi: 10.6061/clinics/2020/e1554. eCollection 2020.

    PubMed 32215455

  • Plein LM, Rittner HL. Opioids and the immune system - friend or foe. Br J Pharmacol. 2018 Jul;175(14):2717-2725. doi: 10.1111/bph.13750. Epub 2017 Mar 23.

    PubMed 28213891

  • Vallejo R, de Leon-Casasola O, Benyamin R. Opioid therapy and immunosuppression: a review. Am J Ther. 2004 Sep-Oct;11(5):354-65. doi: 10.1097/01.mjt.0000132250.95650.85.

    PubMed 15356431

  • Finley MJ, Happel CM, Kaminsky DE, Rogers TJ. Opioid and nociceptin receptors regulate cytokine and cytokine receptor expression. Cell Immunol. 2008 Mar-Apr;252(1-2):146-54. doi: 10.1016/j.cellimm.2007.09.008. Epub 2008 Feb 14.

    PubMed 18279847

  • Parkhill AL, Bidlack JM. Reduction of lipopolysaccharide-induced interleukin-6 production by the kappa opioid U50,488 in a mouse monocyte-like cell line. Int Immunopharmacol. 2006 Jun;6(6):1013-9. doi: 10.1016/j.intimp.2006.01.012. Epub 2006 Feb 17.

    PubMed 16644488

  • Busch-Dienstfertig M, Stein C. Opioid receptors and opioid peptide-producing leukocytes in inflammatory pain--basic and therapeutic aspects. Brain Behav Immun. 2010 Jul;24(5):683-94. doi: 10.1016/j.bbi.2009.10.013. Epub 2009 Oct 29.

    PubMed 19879349

  • Stein C, Kuchler S. Non-analgesic effects of opioids: peripheral opioid effects on inflammation and wound healing. Curr Pharm Des. 2012;18(37):6053-69. doi: 10.2174/138161212803582513.

    PubMed 22747536

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Opioid-Based Anesthesia-Analgesia Strategy and Opioid-free Anesthesia-Analgesia Strategy in people with Systemic Inflammatory Response Syndrome and Postoperative Pain, Acute, run by University of Crete at 1 site in Greece.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 29 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Periklis Vasilos, MD (00306978702023, p.vassilos@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Neutrophil to Lymphocyte ratio (NLR) (time frame: Preoperatively). The study lists 101 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05172739, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in