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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.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

Benjamin Jonke, M.D. contact

+38651639694

benjamin.jonke@gmail.com

Maja Šoštarič, PhD contact

+38631 859 462

dr.maja.sostaric@gmail.com

Slovenia1 site, 1 recruiting
  • University Medical Centre Ljubljana

    Ljubljana, 1000

    University Medical Centre Ljubljana, +3861 522 14 33, razvoj.anestezija@kclj.si

    Recruiting

Other trials in Slovenia

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.

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 groups in NCT05248152
Study groupRoleWhat they receive
PlaceboPlacebo comparatorPatients will receive a placebo capsule in the hour before surgery and two intravenous doses of saline before surgical incision.
Receives: Drug: Placebo
PregabalinExperimentalPatients 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 IbuprofenExperimentalPatients 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.

  1. 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

  2. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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.

  1. First posted21 Feb 2022
  2. Study start13 Jan 2022
  3. Primary completion13 Jan 2024 (estimated)
  4. Study completion13 Apr 2024 (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 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)
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 33456877
  • Hadzic 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 15851888
  • Dunkman 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 30390850
  • Nimmo 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 28873505
  • Simpson 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 30833861
  • Wick 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 28564673
  • Rosero 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 25255012
  • Kelly 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 11698320
  • Doleman 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 26469366
  • Ong 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 15728066
  • Wang 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 28936554
  • Esparza-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 29243848
  • Ong 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 20142348
  • Mishriky 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 25209095
  • Calandre 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

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.

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