Effect of Psychosocial and Psychophysical Factors and Preemptive Analgesia on Postoperative Pain in Upper Limb Surgery

NCT05248152 | Unknown

• 1 other identifier: 0120-182/2021/8
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (2)

• Opioid consumption in the first 24 hours

  Piritramide consumption will be obtained from the PCA pumb, manual boluses will be added.

  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

  First 24 hours, starting at time of surgery

Secondary Outcomes (8)

• The incidence of chronic pain

  Three months after surgery

• Sleep quality on the night after surgery

  First 24 hours, starting at time of surgery

• Opioid consumption in the first 24 hours in correlation with preoperative Pain catastrophising scale (PCS)

  First 24 hours, starting at time of surgery

• Worst pain in the first 24 hours in correlation with preoperative Pain catastrophising scale (PCS)

  First 24 hours, starting at time of surgery

• Opioid consumption in the first 24 hours in correlation with preoperative Conditioned pain modulation (CPM)

  First 24 hours, starting at time of surgery

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Patients will receive a placebo capsule in the hour before surgery and two intravenous doses of saline before surgical incision.

Drug: Placebo

Pregabalin

EXPERIMENTAL

Patients will receive pregabalin 150 mg in the hour before surgery and two intravenous doses of saline before surgical incision.

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.

Combination Product: Paracetamol and Ibuprofen

Interventions

Paracetamol and Ibuprofen COMBINATION_PRODUCT

Patients will receive paracetamol 1g and ibuprofen 400 mg before surgical incision.

Paracetamol and Ibuprofen

Pregabalin 150mg DRUG

Patients will receive pregabalin 150 mg in the hour before surgery

Pregabalin

Placebo DRUG

Patients will receive a placebo capsule in the hour before surgery and two intravenous doses of saline before surgical incision.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists (ASA) classification score 1 and 2
• Patients with a distal radius fracture, scheduled for surgery

You may not qualify if:

• 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
• Chronic kidney disease stage 3 or higher
• Diabetes
• Psychiatric illness

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (1)

University Medical Centre Ljubljana

Ljubljana, 1000, Slovenia

RECRUITING

Related Publications (38)

• 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.

  PMID: 33456877 BACKGROUND

• 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.

  PMID: 15851888 BACKGROUND

• 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.

  PMID: 30390850 BACKGROUND

• 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.

  PMID: 28873505 BACKGROUND

• 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.

  PMID: 30833861 BACKGROUND

• 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.

  PMID: 28564673 BACKGROUND

• 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.

  PMID: 25255012 BACKGROUND

• 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.

  PMID: 11698320 BACKGROUND

• 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.

  PMID: 26469366 BACKGROUND

• 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.

  PMID: 15728066 BACKGROUND

• 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.

  PMID: 28936554 BACKGROUND

• 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.

  PMID: 29243848 BACKGROUND

• 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.

  PMID: 20142348 BACKGROUND

• 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.

  PMID: 25209095 BACKGROUND

• 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.

  PMID: 27345098 BACKGROUND

• Khalili G, Janghorbani M, Saryazdi H, Emaminejad A. Effect of preemptive and preventive acetaminophen on postoperative pain score: a randomized, double-blind trial of patients undergoing lower extremity surgery. J Clin Anesth. 2013 May;25(3):188-92. doi: 10.1016/j.jclinane.2012.09.004. Epub 2013 Apr 6.

  PMID: 23567482 BACKGROUND

• Boonriong T, Tangtrakulwanich B, Glabglay P, Nimmaanrat S. Comparing etoricoxib and celecoxib for preemptive analgesia for acute postoperative pain in patients undergoing arthroscopic anterior cruciate ligament reconstruction: a randomized controlled trial. BMC Musculoskelet Disord. 2010 Oct 25;11:246. doi: 10.1186/1471-2474-11-246.

  PMID: 20973952 BACKGROUND

• Wang J, Li H, Ma H, Wang N. Effect of Preemptive Flurbiprofen Axetil and Tramadol on Transurethral Resection of the Prostate under Spinal Anesthesia. Pain Res Treat. 2016;2016:3942040. doi: 10.1155/2016/3942040. Epub 2016 Feb 9.

  PMID: 26977315 BACKGROUND

• Khezri MB, Mosallaei MA, Ebtehaj M, Mohammadi N. Comparison of preemptive effect of intravenous ketorolac versus meperidine on postoperative shivering and pain in patients undergoing cesarean section under spinal anesthesia: A prospective, randomized, double-blind study. Caspian J Intern Med. 2018 Spring;9(2):151-157. doi: 10.22088/cjim.9.2.151.

  PMID: 29732033 BACKGROUND

• Demir U, Ince I, Aksoy M, Dostbil A, Ari MA, Sulak MM, Kose M, Tanios M, Ozmen O. The Effect of Pre-emptive Dexketoprofen Administration on Postoperative Pain Management in Patients with Ultrasound Guided Interscalene Block in Arthroscopic Shoulder Surgery. J Invest Surg. 2021 Jan;34(1):82-88. doi: 10.1080/08941939.2019.1576809. Epub 2019 Apr 9.

  PMID: 30966835 BACKGROUND

• Park M, Lee H, Jeon Y. Preoperative pregabalin prolongs duration of spinal anesthesia and reduces early postoperative pain: A double-blind, randomized clinical CONSORT study. Medicine (Baltimore). 2016 Sep;95(36):e4828. doi: 10.1097/MD.0000000000004828.

  PMID: 27603398 BACKGROUND

• Akhavanakbari G, Entezariasl M, Isazadehfar K, Mirzarahimi T. The effects of oral pregabalin on post-operative pain of lower limb orthopedic surgery: A double-blind, placebo-controlled trial. Perspect Clin Res. 2013 Jul;4(3):165-8. doi: 10.4103/2229-3485.115376.

  PMID: 24010057 BACKGROUND

• Bafna U, Rajarajeshwaran K, Khandelwal M, Verma AP. A comparison of effect of preemptive use of oral gabapentin and pregabalin for acute post-operative pain after surgery under spinal anesthesia. J Anaesthesiol Clin Pharmacol. 2014 Jul;30(3):373-7. doi: 10.4103/0970-9185.137270.

  PMID: 25190946 BACKGROUND

• Omara AF, Ahmed SA, Abusabaa MM. The Effect Of The Use Of Pre-Emptive Oral Pregabalin On The Postoperative Spinal Analgesia In Patients Presented For Orthopedic Surgeries: Randomized Controlled Trial. J Pain Res. 2019 Sep 30;12:2807-2814. doi: 10.2147/JPR.S216184. eCollection 2019.

  PMID: 31686901 BACKGROUND

• Cegin MB, Soyoral L, Yuzkat N, Baydi V, Goktas U. Pregabalin administered as an anxiolytic agent in ultrasound-guided infraclavicular block: a controlled, double-blind, dose-ranging trial. Eur Rev Med Pharmacol Sci. 2016;20(3):568-74.

  PMID: 26914135 BACKGROUND

• Gatchel RJ, McGeary DD, McGeary CA, Lippe B. Interdisciplinary chronic pain management: past, present, and future. Am Psychol. 2014 Feb-Mar;69(2):119-30. doi: 10.1037/a0035514.

  PMID: 24547798 BACKGROUND

• Tuna T, Boz S, Van Obbergh L, Lubansu A, Engelman E. Comparison of the Pain Sensitivity Questionnaire and the Pain Catastrophizing Scale in Predicting Postoperative Pain and Pain Chronicization After Spine Surgery. Clin Spine Surg. 2018 Nov;31(9):E432-E440. doi: 10.1097/BSD.0000000000000694.

  PMID: 30036209 BACKGROUND

• Wright D, Hoang M, Sofine A, Silva JP, Schwarzkopf R. Pain catastrophizing as a predictor for postoperative pain and opiate consumption in total joint arthroplasty patients. Arch Orthop Trauma Surg. 2017 Dec;137(12):1623-1629. doi: 10.1007/s00402-017-2812-x. Epub 2017 Oct 3.

  PMID: 28975493 BACKGROUND

• Granot M, Ferber SG. The roles of pain catastrophizing and anxiety in the prediction of postoperative pain intensity: a prospective study. Clin J Pain. 2005 Sep-Oct;21(5):439-45. doi: 10.1097/01.ajp.0000135236.12705.2d.

  PMID: 16093750 BACKGROUND

• Khan RS, Skapinakis P, Ahmed K, Stefanou DC, Ashrafian H, Darzi A, Athanasiou T. The association between preoperative pain catastrophizing and postoperative pain intensity in cardiac surgery patients. Pain Med. 2012 Jun;13(6):820-7. doi: 10.1111/j.1526-4637.2012.01386.x. Epub 2012 May 8.

  PMID: 22568812 BACKGROUND

• Burns LC, Ritvo SE, Ferguson MK, Clarke H, Seltzer Z, Katz J. Pain catastrophizing as a risk factor for chronic pain after total knee arthroplasty: a systematic review. J Pain Res. 2015 Jan 5;8:21-32. doi: 10.2147/JPR.S64730. eCollection 2015.

  PMID: 25609995 BACKGROUND

• Treede RD. The role of quantitative sensory testing in the prediction of chronic pain. Pain. 2019 May;160 Suppl 1:S66-S69. doi: 10.1097/j.pain.0000000000001544.

  PMID: 31008852 BACKGROUND

• Schreiber KL, Zinboonyahgoon N, Xu X, Spivey T, King T, Dominici L, Partridge A, Golshan M, Strichartz G, Edwards RR. Preoperative Psychosocial and Psychophysical Phenotypes as Predictors of Acute Pain Outcomes After Breast Surgery. J Pain. 2019 May;20(5):540-556. doi: 10.1016/j.jpain.2018.11.004. Epub 2018 Nov 23.

  PMID: 30476655 BACKGROUND

• van Helmond N, Aarts HM, Timmerman H, Olesen SS, Drewes AM, Wilder-Smith OH, Steegers MA, Vissers KC. Is Preoperative Quantitative Sensory Testing Related to Persistent Postsurgical Pain? A Systematic Literature Review. Anesth Analg. 2020 Oct;131(4):1146-1155. doi: 10.1213/ANE.0000000000004871.

  PMID: 32925335 BACKGROUND

• Sangesland A, Storen C, Vaegter HB. Are preoperative experimental pain assessments correlated with clinical pain outcomes after surgery? A systematic review. Scand J Pain. 2017 Apr;15:44-52. doi: 10.1016/j.sjpain.2016.12.002. Epub 2016 Dec 19.

  PMID: 28850344 BACKGROUND

• Fernandes C, Pidal-Miranda M, Samartin-Veiga N, Carrillo-de-la-Pena MT. Conditioned pain modulation as a biomarker of chronic pain: a systematic review of its concurrent validity. Pain. 2019 Dec;160(12):2679-2690. doi: 10.1097/j.pain.0000000000001664.

  PMID: 31365469 BACKGROUND

• Arendt-Nielsen L, Egsgaard LL, Petersen KK, Eskehave TN, Graven-Nielsen T, Hoeck HC, Simonsen O. A mechanism-based pain sensitivity index to characterize knee osteoarthritis patients with different disease stages and pain levels. Eur J Pain. 2015 Nov;19(10):1406-17. doi: 10.1002/ejp.651. Epub 2014 Dec 29.

  PMID: 25545011 BACKGROUND

• Petersen KK, Graven-Nielsen T, Simonsen O, Laursen MB, Arendt-Nielsen L. Preoperative pain mechanisms assessed by cuff algometry are associated with chronic postoperative pain relief after total knee replacement. Pain. 2016 Jul;157(7):1400-1406. doi: 10.1097/j.pain.0000000000000531.

  PMID: 27331347 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Acetaminophen; Ibuprofen; Pregabalin

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Benjamin Jonke, M.D.

  University Medical Centre Ljubljana

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Benjamin Jonke, M.D.

CONTACT

+38651639694; benjamin.jonke@gmail.com

Maja Šoštarič, PhD

CONTACT

+38631 859 462; dr.maja.sostaric@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants will receive either the actual drug or placebo. A separate investigator will be in charge of preparing the capsules and intravenous solutions that patients will receive before surgery in a way that it will not be possible to determine whether it is an actual drug or a placebo. That investigator will also write in which group the patient is on a piece of paper and insert it in the patient's inventory for safety purposes. The person that will measure the conditioned pain modulation and complete the pain questionnaires with patients will be a separate investigator. The anesthesiologist performing the axillary block will also be blinded, because the drugs/placebo will be prepared by a separate investigator. We will code the group to which the patients are allocated, so that the Outcomes Assessor will also be blinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor of Medicine

Model Details: Three groups of patients with three different treatment regimens

Study Record Dates

• First Submitted: February 9, 2022
• First Posted: February 21, 2022
• Study Start: January 13, 2022
• Primary Completion: January 13, 2024
• Study Completion: April 13, 2024
• Last Updated: February 21, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Immediately following publication. No end date.
• Access Criteria: Anyone who wishes to access the data.

Locations

SL (1)