drugset / Trial / NCT05248152
Effect of Psychosocial and Psychophysical Factors and Preemptive Analgesia on Postoperative Pain in Upper Limb Surgery
RandomizedParallel-groupQuadruple-blindPrevention
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.
Timeline
- Start
- 2022-01-13
- Primary completion
- 2024-01-13
- Completion
- 2024-04-13
Publications
- Background 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Acetaminophen | Small molecule | 1 g | Intravenous |
| Subject | Ibuprofen | Small molecule | 400 mg | Intravenous |
| Subject | Pregabalin | Small molecule | 150 mg | Oral |
Indications
No indication recorded.