drugset / Trial / NCT02160301
Effect of a Multimodal Pain Regimen on Pain Control, Patient Satisfaction and Narcotic Use in Orthopaedic Trauma Patients
RandomizedParallel-groupOpen-labelTreatment
Summary
The study is a prospective, randomized, open-label comparison of a multimodal regimen and a standard, narcotic-based regimen for postoperative pain control in patients undergoing surgery for an operatively indicated, isolated extremity fracture. The investigators will be measuring pain levels, narcotic use, patient satisfaction, patient reported function, adverse events and fracture union. The investigators hypothesize that this multimodal regimen will lead to improved pain, less narcotic use and improved satisfaction as compared to the standard regimen.
Timeline
- Start
- 2017-11
- Primary completion
- 2019-12
- Completion
- 2019-12
Publications
- Background Kang H, Ha YC, Kim JY, Woo YC, Lee JS, Jang EC. Effectiveness of multimodal pain management after bipolar hemiarthroplasty for hip fracture: a randomized, controlled study. J Bone Joint Surg Am. 2013 Feb 20;95(4):291-6. doi: 10.2106/JBJS.K.01708.
- Background Maheshwari AV, Boutary M, Yun AG, Sirianni LE, Dorr LD. Multimodal analgesia without routine parenteral narcotics for total hip arthroplasty. Clin Orthop Relat Res. 2006 Dec;453:231-8. doi: 10.1097/01.blo.0000246545.72445.c4.
- Background Kashefi P, Honarmand A, Safavi M. Effects of preemptive analgesia with celecoxib or acetaminophen on postoperative pain relief following lower extremity orthopedic surgery. Adv Biomed Res. 2012;1:66. doi: 10.4103/2277-9175.100197. Epub 2012 Aug 28.
- Background Panah Khahi M, Yaghooti AA, Marashi SH, Nadjafi A. Effect of pre-emptive gabapentin on postoperative pain following lower extremity orthopaedic surgery under spinal anaesthesia. Singapore Med J. 2011 Dec;52(12):879-82.
- Background Montazeri K, Kashefi P, Honarmand A. Pre-emptive gabapentin significantly reduces postoperative pain and morphine demand following lower extremity orthopaedic surgery. Singapore Med J. 2007 Aug;48(8):748-51.
- Background Ho KY, Gan TJ, Habib AS. Gabapentin and postoperative pain--a systematic review of randomized controlled trials. Pain. 2006 Dec 15;126(1-3):91-101. doi: 10.1016/j.pain.2006.06.018. Epub 2006 Jul 18.
- Background Yadeau JT, Paroli L, Kahn RL, Jules-Elysee KM, Lasala VR, Liu SS, Lin E, Powell K, Buschiazzo VL, Wukovits B, Roberts MM, Levine DS. Addition of pregabalin to multimodal analgesic therapy following ankle surgery: a randomized double-blind, placebo-controlled trial. Reg Anesth Pain Med. 2012 May-Jun;37(3):302-7. doi: 10.1097/AAP.0b013e31824c6846.
- 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 Rajpal S, Gordon DB, Pellino TA, Strayer AL, Brost D, Trost GR, Zdeblick TA, Resnick DK. Comparison of perioperative oral multimodal analgesia versus IV PCA for spine surgery. J Spinal Disord Tech. 2010 Apr;23(2):139-45. doi: 10.1097/BSD.0b013e3181cf07ee.
- Background Hebl JR, Dilger JA, Byer DE, Kopp SL, Stevens SR, Pagnano MW, Hanssen AD, Horlocker TT. A pre-emptive multimodal pathway featuring peripheral nerve block improves perioperative outcomes after major orthopedic surgery. Reg Anesth Pain Med. 2008 Nov-Dec;33(6):510-7.
- Background Cho CH, Song KS, Min BW, Lee KJ, Ha E, Lee YC, Lee YK. Multimodal approach to postoperative pain control in patients undergoing rotator cuff repair. Knee Surg Sports Traumatol Arthrosc. 2011 Oct;19(10):1744-8. doi: 10.1007/s00167-010-1294-y. Epub 2010 Oct 19.
- Background Goldstein RY, Montero N, Jain SK, Egol KA, Tejwani NC. Efficacy of popliteal block in postoperative pain control after ankle fracture fixation: a prospective randomized study. J Orthop Trauma. 2012 Oct;26(10):557-61. doi: 10.1097/BOT.0b013e3182638b25.
- Background VanDenKerkhof EG, Hopman WM, Goldstein DH, Wilson RA, Towheed TE, Lam M, Harrison MB, Reitsma ML, Johnston SL, Medd JD, Gilron I. Impact of perioperative pain intensity, pain qualities, and opioid use on chronic pain after surgery: a prospective cohort study. Reg Anesth Pain Med. 2012 Jan-Feb;37(1):19-27. doi: 10.1097/AAP.0b013e318237516e.
- Background Carroll I, Barelka P, Wang CK, Wang BM, Gillespie MJ, McCue R, Younger JW, Trafton J, Humphreys K, Goodman SB, Dirbas F, Whyte RI, Donington JS, Cannon WB, Mackey SC. A pilot cohort study of the determinants of longitudinal opioid use after surgery. Anesth Analg. 2012 Sep;115(3):694-702. doi: 10.1213/ANE.0b013e31825c049f. Epub 2012 Jun 22.
- Background Lamplot JD, Wagner ER, Manning DW. Multimodal pain management in total knee arthroplasty: a prospective randomized controlled trial. J Arthroplasty. 2014 Feb;29(2):329-34. doi: 10.1016/j.arth.2013.06.005. Epub 2013 Jul 11.
- Background Remerand F, Le Tendre C, Baud A, Couvret C, Pourrat X, Favard L, Laffon M, Fusciardi J. The early and delayed analgesic effects of ketamine after total hip arthroplasty: a prospective, randomized, controlled, double-blind study. Anesth Analg. 2009 Dec;109(6):1963-71. doi: 10.1213/ANE.0b013e3181bdc8a0.
- Background Ayalon O, Liu S, Flics S, Cahill J, Juliano K, Cornell CN. A multimodal clinical pathway can reduce length of stay after total knee arthroplasty. HSS J. 2011 Feb;7(1):9-15. doi: 10.1007/s11420-010-9164-1. Epub 2010 May 22.
- Background Fu PL, Xiao J, Zhu YL, Wu HS, Li XH, Wu YL, Qian QR. Efficacy of a multimodal analgesia protocol in total knee arthroplasty: a randomized, controlled trial. J Int Med Res. 2010 Jul-Aug;38(4):1404-12. doi: 10.1177/147323001003800422.
- Background Ho KY, Tay W, Yeo MC, Liu H, Yeo SJ, Chia SL, Lo NN. Duloxetine reduces morphine requirements after knee replacement surgery. Br J Anaesth. 2010 Sep;105(3):371-6. doi: 10.1093/bja/aeq158. Epub 2010 Jun 23.
- Background Rasmussen ML, Mathiesen O, Dierking G, Christensen BV, Hilsted KL, Larsen TK, Dahl JB. Multimodal analgesia with gabapentin, ketamine and dexamethasone in combination with paracetamol and ketorolac after hip arthroplasty: a preliminary study. Eur J Anaesthesiol. 2010 Apr;27(4):324-30. doi: 10.1097/EJA.0b013e328331c71d.
- Background Huang YM, Wang CM, Wang CT, Lin WP, Horng LC, Jiang CC. Perioperative celecoxib administration for pain management after total knee arthroplasty - a randomized, controlled study. BMC Musculoskelet Disord. 2008 Jun 3;9:77. doi: 10.1186/1471-2474-9-77.
- Background Woolf CJ, Chong MS. Preemptive analgesia--treating postoperative pain by preventing the establishment of central sensitization. Anesth Analg. 1993 Aug;77(2):362-79. doi: 10.1213/00000539-199377020-00026. No abstract available.
- Background Aida S, Fujihara H, Taga K, Fukuda S, Shimoji K. Involvement of presurgical pain in preemptive analgesia for orthopedic surgery: a randomized double blind study. Pain. 2000 Feb;84(2-3):169-73. doi: 10.1016/s0304-3959(99)00196-7.
- Background Jensen MP, Chen C, Brugger AM. Interpretation of visual analog scale ratings and change scores: a reanalysis of two clinical trials of postoperative pain. J Pain. 2003 Sep;4(7):407-14. doi: 10.1016/s1526-5900(03)00716-8.
- Background Woodside JR. Female smokers have increased postoperative narcotic requirements. J Addict Dis. 2000;19(4):1-10. doi: 10.1300/J069v19n04_01.
- Background Gorocs TS, Lambert M, Rinne T, Krekler M, Modell S. Efficacy and tolerability of ready-to-use intravenous paracetamol solution as monotherapy or as an adjunct analgesic therapy for postoperative pain in patients undergoing elective ambulatory surgery: open, prospective study. Int J Clin Pract. 2009 Jan;63(1):112-20. doi: 10.1111/j.1742-1241.2008.01914.x.
- Background He BJ, Tong PJ, Li J, Jing HT, Yao XM. Auricular acupressure for analgesia in perioperative period of total knee arthroplasty. Pain Med. 2013 Oct;14(10):1608-13. doi: 10.1111/pme.12197. Epub 2013 Jul 18.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Acetaminophen | Small molecule | 1000 mg | Oral |
| Subject | Celecoxib | Other / unclassified | 400 mg | Oral |
| Subject | Dexamethasone | Small molecule | 8 mg | Intravenous |
| Subject | Gabapentin | Small molecule | 200 mg | Oral |
| Background | Oxycodone | Other / unclassified | 5 mg | Oral |
| Background | Oxycodone | Other / unclassified | 15 mg | Oral |
Indications
No indication recorded.