Postoperative PainNCT05248152
Effect of Psychosocial and Psychophysical Factors and Preemptive Analgesia on Postoperative Pain in Upper Limb Surgery
A study testing Paracetamol and Ibuprofen and Pregabalin 150mg in people with Postoperative Pain, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial summary
The purpose of this study is to define the role of preemptive systemic analgesia in combination with regional anesthetic techniques on postoperative pain following upper limb surgery in different subgroups of patients with different psychosocial and psychophysical characteristics. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Paracetamol and Ibuprofen and Pregabalin 150mg
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteSlovenia
- Study dates
- 13 Jan 2022to 13 Apr 2024
- Phase
- Interventional
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) classification score 1 and 2
- Patients with a distal radius fracture, scheduled for surgery
Who cannot join
- Allergy to a local anesthetic, opioid, paracetamol or a non-steroidal antirheumatic drug
- Opioid addiction
- Infection at the injection site
- Chronic pain syndromes
- Neuropathies
- Liver cirrhosis
Show all 9Show fewer
- Chronic kidney disease stage 3 or higher
- Diabetes
- Psychiatric illness
Trial locations and contacts
1 site in 1 country.
Slovenia1 site, 1 recruiting
- Recruiting
University Medical Centre Ljubljana
Ljubljana, 1000
University Medical Centre Ljubljana, +3861 522 14 33, razvoj.anestezija@kclj.si
About this study
Official title: Psychosocial and Psychophysical Factors Influencing the Effect of Preemptive Systemic Analgesia in Combination With Regional Anesthesia on Postoperative Pain Following Upper Limb Surgery
The purpose of this study is to define the role of preemptive systemic analgesia in combination with regional anesthetic techniques on postoperative pain following upper limb surgery in different subgroups of patients with different psychosocial and psychophysical characteristics.
Read the detailed description
After being informed about the study and potential risks, patients will be given written informed consent. The study will include patients between the ages of 18 and 65, rated 1 or 2 by the American Society of Anesthesiologists (ASA) classification scheduled for distal radius surgery.
We will exclude patients with a known allergy to or adverse reaction to a local anesthetic, opioid, paracetamol or non-steroidal anti-inflammatory drugs, patients with a known opioid dependence, injection site infection, chronic pain, renal disease, known neuropathy, liver disease, with psychiatric disorders and diabetics.
The study will be randomized, prospective and double-blind. We will study the effect of preemptive dose of paracetamol and ibuprofen and pregabalin on postoperative pain after distal radius surgery in patients with different psychosocial and psychophysical characteristics. Patients will be admitted to the ward the day before surgery. At that time, we will explain to them the course of the research and offer them participation. For those with a written consent we will perform preoperative quantitative sensory tests on the same day and give them pain questionnaires.
We will determine conditional pain modulation by first applying a mechanical test stimulus of increasing intensity with an algometer to the skin of the volar side of the forearm and the skin in the middle of the front of the thigh contralateral to the injury until the patient experiences pain on the visual analog scale (VAS) 4/10. At that point the patients will press the patient operated button on the algometer and the stimulus will be stopped with the measurement stored. We will then repeat the same test together with a conditional stimulus - immersion of the ipsilateral lower extremity in cold water at 2 degrees Celsius. Conditional pain modulation will be calculated by subtracting the intensity of the independent primary stimulus from the intensity of the primary stimulus together with a concomitant conditioned stimulus. The end result will be the average of the values obtained on the skin of the volar side of the forearm and the skin in the middle of the front of the thigh.
On the same day the patients will also complete a Pain Catastrophising Scale (PCS) Questionnaire and a Brief Pain Inventory (BPI). They will also receive a short questionnaire to assess the pain and quality of sleep on the first night after surgery, which they will complete together with an anesthesiologist the morning after surgery.
On the day of surgery, patients will be divided into 3 groups:
The first group will receive pregabalin 150 mg per os 1 hour before arrival in the operating room and two intravenous doses of 100 ml of saline within 30 minutes before the surgical incision.
The second group will receive a placebo capsule per os 1 hour before arrival in the operating room and a preemptive intravenous dose of paracetamol 1 g and ibuprofen 400 mg within 30 minutes before the surgical incision.
The third group will receive a placebo capsule per os 1 hour before arrival in the operating room and two intravenous doses of 100 ml of saline within 30 minutes before the surgical incision.
All three groups will then receive an axillary block under ultrasound control by an experienced anesthesiologist. They may receive midazolam and/or fentanyl/sufentanil for anxiolysis and analgesia during the blockade. The surgery will be performed with of without sedation with propofol, titrated to desired effect. In the event of a failed block, patients will be placed under general anesthesia and excluded from the study. For postoperative nausea and vomiting they will not receive dexamethasone.
Postoperative analgesia:
For the postoperative analgesia, patients will receive a PCA (patient controlled analgesia) pump with Piritramide 45 mg diluted to 90 ml of saline. The PCA pump will have no continuous flow. The PCA boluses will be 3 mg every 20 minutes, with a 2 hour limit of 9 mg and a 6 hour limit of 15 mg. The PCA pump will be connected to the patients for at least 24 hours.
If necessary, the ward nurse will administer an additional intravenous dose of Piritramide 3 mg every 4 hours in case of insufficient analgesia (pain on VAS > 3/10). Patients will additionally receive intravenous Paracetamol 1 g every 6 h and intravenous Ibuprofen 400 mg every 8 hours.
For 24 hours after surgery we will record pain experienced by the patients, based on the VAS. Opioid consumption will be recorded by the PCA pump, any additional boluses by the nurses will be added to the total consumption. The first day after surgery, 14 days after surgery and 3 months after surgery the patients will again complete a BPI questionnaire. We will also document the interval between the injury and surgery, time of surgery, AO Distal Radius Fracture Classification, surgical approach and type of osteosynthesis.
We will study the impact of psychosocial, psychophysical and preemptive systemic analgesia on acute and chronic postoperative pain in distal radius surgery. We will examine whether patients with different psychosocial and psychophysical characteristics benefit differently from different regimens of preemptive systemic analgesia.
- Conditions
- Postoperative Pain
- Being tested
- Paracetamol and Ibuprofen, Pregabalin 150mg, Placebo
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paracetamol and IbuprofenCombination product
Patients will receive paracetamol 1g and ibuprofen 400 mg before surgical incision.
Pregabalin 150mgDrug
Patients will receive pregabalin 150 mg in the hour before surgery
PlaceboDrug
Patients will receive a placebo capsule in the hour before surgery and two intravenous doses of saline before surgical incision.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Patients will receive a placebo capsule in the hour before surgery and two intravenous doses of saline before surgical incision. Receives: Drug: Placebo |
| Pregabalin | Experimental | Patients will receive pregabalin 150 mg in the hour before surgery and two intravenous doses of saline before surgical incision. Receives: Drug: Pregabalin 150mg |
| Paracetamol and Ibuprofen | Experimental | Patients will receive a placebo capsule in the hour before surgery and an intravenous dose of paracetamol 1 g and ibuprofen 400 mg before surgical incision. Receives: Combination Product: Paracetamol and Ibuprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid consumption in the first 24 hours
Piritramide consumption will be obtained from the PCA pumb, manual boluses will be added.
Measured: First 24 hours, starting at time of surgery
Worst pain in the first 24 hours
Worst pain in the first 24 hours after surgery on the visual analog scale (VAS) will be obtained the day after surgery
Measured: First 24 hours, starting at time of surgery
Secondary outcomes (8)
The incidence of chronic pain
The presence of chronic pain will be defined as pain persisting at the three month interval
Measured: Three months after surgery
Sleep quality on the night after surgery
Sleep quality will be obtained by a questionnaire, raging from 1-5, where 1 is described as very poor sleep quality and 5 as very good sleep quality
Measured: First 24 hours, starting at time of surgery
Opioid consumption in the first 24 hours in correlation with preoperative Pain catastrophising scale (PCS)
PCS will be obtained preoperatively, we will investigate, whether there is a positive correlation between opioid consumption in the first 24 hours and preoperative PCS greater than 30. PCS is a questionnaire, consisting of 13 questions, each ranging from scores 0 to 4, so the final score is in the range of 0 to 52. A total PCS score of 30 or more represents clinically relevant level of pain catastrophizing.
Measured: First 24 hours, starting at time of surgery
Worst pain in the first 24 hours in correlation with preoperative Pain catastrophising scale (PCS)
PCS will be obtained preoperatively, we will investigate, whether there is a positive correlation between the worst pain in the first 24 hours and preoperative PCS greater than 30. PCS is a questionnaire, consisting of 13 questions, each ranging from scores 0 to 4, so the final score is in the range of 0 to 52. A total PCS score of 30 or more represents clinically relevant level of pain catastrophizing.
Measured: First 24 hours, starting at time of surgery
Opioid consumption in the first 24 hours in correlation with preoperative Conditioned pain modulation (CPM)
CPM will be obtained preoperatively, we will investigate, whether there is a correlation between opioid consumption in the first 24 hours and preoperative CPM. CPM will be determined by first applying a mechanical test stimulus of increasing intensity with an algometer to the skin of the volar side of the forearm and the skin in the middle of the front of the thigh contralateral to the injury until the patient experiences pain on the visual analog scale (VAS) of 4/10. The same stimulus will then be applied together with a conditional stimulus - immersion of the ipsilateral lower extremity in cold water at 2 degrees Celsius. Conditional pain modulation will be calculated by subtracting the intensity of the independent primary stimulus from the intensity of the primary stimulus together with a concomitant conditioned stimulus. CPM is a centrally processed measure of the net effect of the descending pain pathway. Higher CPM scores signify better pain control.
Measured: First 24 hours, starting at time of surgery
Worst pain in the first 24 hours in correlation with preoperative Conditioned pain modulation (CPM)
CPM will be obtained preoperatively, we will investigate, whether there is a correlation between the worst pain in the first 24 hours and preoperative CPM. CPM will be determined by first applying a mechanical test stimulus of increasing intensity with an algometer to the skin of the volar side of the forearm and the skin in the middle of the front of the thigh contralateral to the injury until the patient experiences pain on the visual analog scale (VAS) of 4/10. The same stimulus will then be applied together with a conditional stimulus - immersion of the ipsilateral lower extremity in cold water at 2 degrees Celsius. Conditional pain modulation will be calculated by subtracting the intensity of the independent primary stimulus from the intensity of the primary stimulus together with a concomitant conditioned stimulus. CPM is a centrally processed measure of the net effect of the descending pain pathway. Higher CPM scores signify better pain control.
Measured: First 24 hours, starting at time of surgery
The incidence of chronic pain in correlation with preoperative Conditioned pain modulation (CPM)
CPM will be obtained preoperatively, we will investigate, whether there is a correlation between the incidence of chronic pain at three months after surgery and preoperative CPM. CPM will be determined by first applying a mechanical test stimulus of increasing intensity with an algometer to the skin of the volar side of the forearm and the skin in the middle of the front of the thigh contralateral to the injury until the patient experiences pain on the visual analog scale (VAS) of 4/10. The same stimulus will then be applied together with a conditional stimulus - immersion of the ipsilateral lower extremity in cold water at 2 degrees Celsius. Conditional pain modulation will be calculated by subtracting the intensity of the independent primary stimulus from the intensity of the primary stimulus together with a concomitant conditioned stimulus. CPM is a centrally processed measure of the net effect of the descending pain pathway. Higher CPM scores signify better pain control.
Measured: 3 months after surgery
The incidence of chronic pain in correlation with preoperative Pain catastrophising scale (PCS)
PCS will be obtained preoperatively, we will investigate, whether there is a positive correlation between the incidence of chronic pain at three months after surgery and preoperative PCS greater than 30. PCS is a questionnaire, consisting of 13 questions, each ranging from scores 0 to 4, so the final score is in the range of 0 to 52. A total PCS score of 30 or more represents clinically relevant level of pain catastrophizing.
Measured: 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2022
- Study start13 Jan 2022
- Primary completion13 Jan 2024 (estimated)
- Study completion13 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (38)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three groups of patients with three different treatment regimens
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benjamin Jonke, University Medical Centre Ljubljana
- Investigators
- Benjamin Jonke, M.D., Principal investigator, University Medical Centre Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05248152
- Sponsor's protocol ID
- 0120-182/2021/8
- Status last verified
- Feb 2022
- First submitted
- 9 Feb 2022
- Last updated
- 21 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will include all IPD that underlie results in a publication
Publications
Hewson DW, Oldman M, Bedforth NM. Regional anaesthesia for shoulder surgery. BJA Educ. 2019 Apr;19(4):98-104. doi: 10.1016/j.bjae.2018.12.004. Epub 2019 Feb 6. No abstract available.
PubMed 33456877Hadzic A, Williams BA, Karaca PE, Hobeika P, Unis G, Dermksian J, Yufa M, Thys DM, Santos AC. For outpatient rotator cuff surgery, nerve block anesthesia provides superior same-day recovery over general anesthesia. Anesthesiology. 2005 May;102(5):1001-7. doi: 10.1097/00000542-200505000-00020.
PubMed 15851888Dunkman WJ, Manning MW. Enhanced Recovery After Surgery and Multimodal Strategies for Analgesia. Surg Clin North Am. 2018 Dec;98(6):1171-1184. doi: 10.1016/j.suc.2018.07.005. Epub 2018 Aug 22.
PubMed 30390850Nimmo SM, Foo ITH, Paterson HM. Enhanced recovery after surgery: Pain management. J Surg Oncol. 2017 Oct;116(5):583-591. doi: 10.1002/jso.24814. Epub 2017 Sep 5.
PubMed 28873505Simpson JC, Bao X, Agarwala A. Pain Management in Enhanced Recovery after Surgery (ERAS) Protocols. Clin Colon Rectal Surg. 2019 Mar;32(2):121-128. doi: 10.1055/s-0038-1676477. Epub 2019 Feb 28.
PubMed 30833861Wick EC, Grant MC, Wu CL. Postoperative Multimodal Analgesia Pain Management With Nonopioid Analgesics and Techniques: A Review. JAMA Surg. 2017 Jul 1;152(7):691-697. doi: 10.1001/jamasurg.2017.0898.
PubMed 28564673Rosero EB, Joshi GP. Preemptive, preventive, multimodal analgesia: what do they really mean? Plast Reconstr Surg. 2014 Oct;134(4 Suppl 2):85S-93S. doi: 10.1097/PRS.0000000000000671.
PubMed 25255012Kelly DJ, Ahmad M, Brull SJ. Preemptive analgesia I: physiological pathways and pharmacological modalities. Can J Anaesth. 2001 Nov;48(10):1000-10. doi: 10.1007/BF03016591.
PubMed 11698320Doleman B, Read D, Lund JN, Williams JP. Preventive Acetaminophen Reduces Postoperative Opioid Consumption, Vomiting, and Pain Scores After Surgery: Systematic Review and Meta-Analysis. Reg Anesth Pain Med. 2015 Nov-Dec;40(6):706-12. doi: 10.1097/AAP.0000000000000311.
PubMed 26469366Ong CK, Lirk P, Seymour RA, Jenkins BJ. The efficacy of preemptive analgesia for acute postoperative pain management: a meta-analysis. Anesth Analg. 2005 Mar;100(3):757-773. doi: 10.1213/01.ANE.0000144428.98767.0E.
PubMed 15728066Wang K, Luo J, Zheng L, Luo T. Preoperative flurbiprofen axetil administration for acute postoperative pain: a meta-analysis of randomized controlled trials. J Anesth. 2017 Dec;31(6):852-860. doi: 10.1007/s00540-017-2409-0. Epub 2017 Sep 21.
PubMed 28936554Esparza-Villalpando V, Pozos-Guillen A, Masuoka-Ito D, Gaitan-Fonseca C, Chavarria-Bolanos D. Analgesic efficacy of preoperative dexketoprofen trometamol: A systematic review and meta-analysis. Drug Dev Res. 2018 Mar;79(2):47-57. doi: 10.1002/ddr.21419. Epub 2017 Dec 15.
PubMed 29243848Ong CK, Seymour RA, Lirk P, Merry AF. Combining paracetamol (acetaminophen) with nonsteroidal antiinflammatory drugs: a qualitative systematic review of analgesic efficacy for acute postoperative pain. Anesth Analg. 2010 Apr 1;110(4):1170-9. doi: 10.1213/ANE.0b013e3181cf9281. Epub 2010 Feb 8.
PubMed 20142348Mishriky BM, Waldron NH, Habib AS. Impact of pregabalin on acute and persistent postoperative pain: a systematic review and meta-analysis. Br J Anaesth. 2015 Jan;114(1):10-31. doi: 10.1093/bja/aeu293. Epub 2014 Sep 10.
PubMed 25209095Calandre EP, Rico-Villademoros F, Slim M. Alpha2delta ligands, gabapentin, pregabalin and mirogabalin: a review of their clinical pharmacology and therapeutic use. Expert Rev Neurother. 2016 Nov;16(11):1263-1277. doi: 10.1080/14737175.2016.1202764. Epub 2016 Jul 7.
PubMed 27345098
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychosocial and Psychophysical Factors Influencing the Effect of Preemptive Systemic Analgesia in Combination With Regional Anesthesia on Postoperative Pain Following Upper Limb Surgery
- ClinicalTrials.gov ID
- NCT05248152
- Acronym / sponsor ID
- 0120-182/2021/8
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- 13 Jan 2022 (actual)
- Primary completion
- 13 Jan 2024 (estimated)
- Study completion
- 13 Apr 2024 (estimated)
- First posted
- 21 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to define the role of preemptive systemic analgesia in combination with regional anesthetic techniques on postoperative pain following upper limb surgery in different subgroups of patients with different psychosocial and psychophysical characteristics.
Detailed description
After being informed about the study and potential risks, patients will be given written informed consent. The study will include patients between the ages of 18 and 65, rated 1 or 2 by the American Society of Anesthesiologists (ASA) classification scheduled for distal radius surgery.
We will exclude patients with a known allergy to or adverse reaction to a local anesthetic, opioid, paracetamol or non-steroidal anti-inflammatory drugs, patients with a known opioid dependence, injection site infection, chronic pain, renal disease, known neuropathy, liver disease, with psychiatric disorders and diabetics.
The study will be randomized, prospective and double-blind. We will study the effect of preemptive dose of paracetamol and ibuprofen and pregabalin on postoperative pain after distal radius surgery in patients with different psychosocial and psychophysical characteristics. Patients will be admitted to the ward the day before surgery. At that time, we will explain to them the course of the research and offer them participation. For those with a written consent we will perform preoperative quantitative sensory tests on the same day and give them pain questionnaires.
We will determine conditional pain modulation by first applying a mechanical test stimulus of increasing intensity with an algometer to the skin of the volar side of the forearm and the skin in the middle of the front of the thigh contralateral to the injury until the patient experiences pain on the visual analog scale (VAS) 4/10. At that point the patients will press the patient operated button on the algometer and the stimulus will be stopped with the measurement stored. We will then repeat the same test together with a conditional stimulus - immersion of the ipsilateral lower extremity in cold water at 2 degrees Celsius. Conditional pain modulation will be calculated by subtracting the intensity of the independent primary stimulus from the intensity of the primary stimulus together with a concomitant conditioned stimulus. The end result will be the average of the values obtained on the skin of the volar side of the forearm and the skin in the middle of the front of the thigh.
On the same day the patients will also complete a Pain Catastrophising Scale (PCS) Questionnaire and a Brief Pain Inventory (BPI). They will also receive a short questionnaire to assess the pain and quality of sleep on the first night after surgery, which they will complete together with an anesthesiologist the morning after surgery.
On the day of surgery, patients will be divided into 3 groups:
The first group will receive pregabalin 150 mg per os 1 hour before arrival in the operating room and two intravenous doses of 100 ml of saline within 30 minutes before the surgical incision.
The second group will receive a placebo capsule per os 1 hour before arrival in the operating room and a preemptive intravenous dose of paracetamol 1 g and ibuprofen 400 mg within 30 minutes before the surgical incision.
The third group will receive a placebo capsule per os 1 hour before arrival in the operating room and two intravenous doses of 100 ml of saline within 30 minutes before the surgical incision.
All three groups will then receive an axillary block under ultrasound control by an experienced anesthesiologist. They may receive midazolam and/or fentanyl/sufentanil for anxiolysis and analgesia during the blockade. The surgery will be performed with of without sedation with propofol, titrated to desired effect. In the event of a failed block, patients will be placed under general anesthesia and excluded from the study. For postoperative nausea and vomiting they will not receive dexamethasone.
Postoperative analgesia:
For the postoperative analgesia, patients will receive a PCA (patient controlled analgesia) pump with Piritramide 45 mg diluted to 90 ml of saline. The PCA pump will have no continuous flow. The PCA boluses will be 3 mg every 20 minutes, with a 2 hour limit of 9 mg and a 6 hour limit of 15 mg. The PCA pump will be connected to the patients for at least 24 hours.
If necessary, the ward nurse will administer an additional intravenous dose of Piritramide 3 mg every 4 hours in case of insufficient analgesia (pain on VAS > 3/10). Patients will additionally receive intravenous Paracetamol 1 g every 6 h and intravenous Ibuprofen 400 mg every 8 hours.
For 24 hours after surgery we will record pain experienced by the patients, based on the VAS. Opioid consumption will be recorded by the PCA pump, any additional boluses by the nurses will be added to the total consumption. The first day after surgery, 14 days after surgery and 3 months after surgery the patients will again complete a BPI questionnaire. We will also document the interval between the injury and surgery, time of surgery, AO Distal Radius Fracture Classification, surgical approach and type of osteosynthesis.
We will study the impact of psychosocial, psychophysical and preemptive systemic analgesia on acute and chronic postoperative pain in distal radius surgery. We will examine whether patients with different psychosocial and psychophysical characteristics benefit differently from different regimens of preemptive systemic analgesia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Three groups of patients with three different treatment regimens
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPatients will receive a placebo capsule in the hour before surgery and two intravenous doses of saline before surgical incision. |
| Pregabalin | Experimental | Drug: Pregabalin 150mgPatients will receive pregabalin 150 mg in the hour before surgery and two intravenous doses of saline before surgical incision. |
| Paracetamol and Ibuprofen | Experimental | Combination Product: Paracetamol and IbuprofenPatients will receive a placebo capsule in the hour before surgery and an intravenous dose of paracetamol 1 g and ibuprofen 400 mg before surgical incision. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists (ASA) classification score 1 and 2
- Patients with a distal radius fracture, scheduled for surgery
Key exclusion criteria (9 listed)
- Allergy to a local anesthetic, opioid, paracetamol or a non-steroidal antirheumatic drug
- Opioid addiction
- Infection at the injection site
- Chronic pain syndromes
- Neuropathies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paracetamol and IbuprofenPatients will receive paracetamol 1g and ibuprofen 400 mg before surgical incision. | Combination product | Paracetamol and Ibuprofen |
| Pregabalin 150mgPatients will receive pregabalin 150 mg in the hour before surgery | Drug | Pregabalin |
| PlaceboPatients will receive a placebo capsule in the hour before surgery and two intravenous doses of saline before surgical incision. | Drug | Placebo |
Primary outcome
Opioid consumption in the first 24 hours
Time frame: First 24 hours, starting at time of surgery
Piritramide consumption will be obtained from the PCA pumb, manual boluses will be added.
Worst pain in the first 24 hours
Time frame: First 24 hours, starting at time of surgery
Worst pain in the first 24 hours after surgery on the visual analog scale (VAS) will be obtained the day after surgery
8 secondary outcomes
The incidence of chronic pain
Time frame: Three months after surgery
Sleep quality on the night after surgery
Time frame: First 24 hours, starting at time of surgery
Opioid consumption in the first 24 hours in correlation with preoperative Pain catastrophising scale (PCS)
Time frame: First 24 hours, starting at time of surgery
Worst pain in the first 24 hours in correlation with preoperative Pain catastrophising scale (PCS)
Time frame: First 24 hours, starting at time of surgery
Opioid consumption in the first 24 hours in correlation with preoperative Conditioned pain modulation (CPM)
Time frame: First 24 hours, starting at time of surgery
Worst pain in the first 24 hours in correlation with preoperative Conditioned pain modulation (CPM)
Time frame: First 24 hours, starting at time of surgery
The incidence of chronic pain in correlation with preoperative Conditioned pain modulation (CPM)
Time frame: 3 months after surgery
The incidence of chronic pain in correlation with preoperative Pain catastrophising scale (PCS)
Time frame: 3 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2022.
- Background: PubMed 33456877Hewson DW, Oldman M, Bedforth NM. Regional anaesthesia for shoulder surgery. BJA Educ. 2019 Apr;19(4):98-104. doi: 10.1016/j.bjae.2018.12.004. Epub 2019 Feb 6. No abstract available.
- Background: PubMed 15851888Hadzic A, Williams BA, Karaca PE, Hobeika P, Unis G, Dermksian J, Yufa M, Thys DM, Santos AC. For outpatient rotator cuff surgery, nerve block anesthesia provides superior same-day recovery over general anesthesia. Anesthesiology. 2005 May;102(5):1001-7. doi: 10.1097/00000542-200505000-00020.
- Background: PubMed 30390850Dunkman WJ, Manning MW. Enhanced Recovery After Surgery and Multimodal Strategies for Analgesia. Surg Clin North Am. 2018 Dec;98(6):1171-1184. doi: 10.1016/j.suc.2018.07.005. Epub 2018 Aug 22.
- Background: PubMed 28873505Nimmo SM, Foo ITH, Paterson HM. Enhanced recovery after surgery: Pain management. J Surg Oncol. 2017 Oct;116(5):583-591. doi: 10.1002/jso.24814. Epub 2017 Sep 5.
- Background: PubMed 30833861Simpson JC, Bao X, Agarwala A. Pain Management in Enhanced Recovery after Surgery (ERAS) Protocols. Clin Colon Rectal Surg. 2019 Mar;32(2):121-128. doi: 10.1055/s-0038-1676477. Epub 2019 Feb 28.
- Background: PubMed 28564673Wick EC, Grant MC, Wu CL. Postoperative Multimodal Analgesia Pain Management With Nonopioid Analgesics and Techniques: A Review. JAMA Surg. 2017 Jul 1;152(7):691-697. doi: 10.1001/jamasurg.2017.0898.
- Background: PubMed 25255012Rosero EB, Joshi GP. Preemptive, preventive, multimodal analgesia: what do they really mean? Plast Reconstr Surg. 2014 Oct;134(4 Suppl 2):85S-93S. doi: 10.1097/PRS.0000000000000671.
- Background: PubMed 11698320Kelly DJ, Ahmad M, Brull SJ. Preemptive analgesia I: physiological pathways and pharmacological modalities. Can J Anaesth. 2001 Nov;48(10):1000-10. doi: 10.1007/BF03016591.
- Background: PubMed 26469366Doleman B, Read D, Lund JN, Williams JP. Preventive Acetaminophen Reduces Postoperative Opioid Consumption, Vomiting, and Pain Scores After Surgery: Systematic Review and Meta-Analysis. Reg Anesth Pain Med. 2015 Nov-Dec;40(6):706-12. doi: 10.1097/AAP.0000000000000311.
- Background: PubMed 15728066Ong CK, Lirk P, Seymour RA, Jenkins BJ. The efficacy of preemptive analgesia for acute postoperative pain management: a meta-analysis. Anesth Analg. 2005 Mar;100(3):757-773. doi: 10.1213/01.ANE.0000144428.98767.0E.
- Background: PubMed 28936554Wang K, Luo J, Zheng L, Luo T. Preoperative flurbiprofen axetil administration for acute postoperative pain: a meta-analysis of randomized controlled trials. J Anesth. 2017 Dec;31(6):852-860. doi: 10.1007/s00540-017-2409-0. Epub 2017 Sep 21.
- Background: PubMed 29243848Esparza-Villalpando V, Pozos-Guillen A, Masuoka-Ito D, Gaitan-Fonseca C, Chavarria-Bolanos D. Analgesic efficacy of preoperative dexketoprofen trometamol: A systematic review and meta-analysis. Drug Dev Res. 2018 Mar;79(2):47-57. doi: 10.1002/ddr.21419. Epub 2017 Dec 15.
- Individual participant dataSharing planned: Yes. We will include all IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin Jonke, M.D. principal investigator
University Medical Centre Ljubljana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paracetamol and Ibuprofen and Pregabalin 150mg in people with Postoperative Pain, run by University Medical Centre Ljubljana at 1 site in Slovenia.
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 9 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 21 Feb 2022. 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 Slovenia. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Benjamin Jonke, M.D. (+38651639694, benjamin.jonke@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid consumption in the first 24 hours (time frame: First 24 hours, starting at time of surgery). The study lists 2 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 NCT05248152, which also lists 38 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 21 Feb 2022.