drugset / Trial / NCT04813991
Pain Control Without Opioids
RandomizedParallel-groupQuadruple-blindTreatment
Summary
Adequate outpatient pain control after uncomplicated laparoscopic appendectomy or cholecystectomy can be achieved with minimal breakthrough drugs when used in combination with around the clock non-opioid medications.
Timeline
- Start
- 2022-03-15
- Primary completion
- 2025-09-01
- Completion
- 2025-09-01
Publications
- Background Gostin LO, Hodge JG Jr, Noe SA. Reframing the Opioid Epidemic as a National Emergency. JAMA. 2017 Oct 24;318(16):1539-1540. doi: 10.1001/jama.2017.13358. No abstract available.
- Background Tan WH, Yu J, Feaman S, McAllister JM, Kahan LG, Quasebarth MA, Blatnik JA, Eagon JC, Awad MM, Brunt LM. Opioid Medication Use in the Surgical Patient: An Assessment of Prescribing Patterns and Use. J Am Coll Surg. 2018 Aug;227(2):203-211. doi: 10.1016/j.jamcollsurg.2018.04.032. Epub 2018 May 7.
- Background Neuman MD, Bateman BT, Wunsch H. Inappropriate opioid prescription after surgery. Lancet. 2019 Apr 13;393(10180):1547-1557. doi: 10.1016/S0140-6736(19)30428-3.
- Background White PF, Joshi GP, Carpenter RL, Fragen RJ. A comparison of oral ketorolac and hydrocodone-acetaminophen for analgesia after ambulatory surgery: arthroscopy versus laparoscopic tubal ligation. Anesth Analg. 1997 Jul;85(1):37-43. doi: 10.1097/00000539-199707000-00007.
- Background Singla N, Pong A, Newman K; MD-10 Study Group. Combination oxycodone 5 mg/ibuprofen 400 mg for the treatment of pain after abdominal or pelvic surgery in women: a randomized, double-blind, placebo- and active-controlled parallel-group study. Clin Ther. 2005 Jan;27(1):45-57. doi: 10.1016/j.clinthera.2005.01.010.
- Background Mitchell A, van Zanten SV, Inglis K, Porter G. A randomized controlled trial comparing acetaminophen plus ibuprofen versus acetaminophen plus codeine plus caffeine after outpatient general surgery. J Am Coll Surg. 2008 Mar;206(3):472-9. doi: 10.1016/j.jamcollsurg.2007.09.006. Epub 2007 Nov 26.
- Background Kroll PB, Meadows L, Rock A, Pavliv L. A multicenter, randomized, double-blind, placebo-controlled trial of intravenous ibuprofen (i.v.-ibuprofen) in the management of postoperative pain following abdominal hysterectomy. Pain Pract. 2011 Jan-Feb;11(1):23-32. doi: 10.1111/j.1533-2500.2010.00402.x.
- Background Ahiskalioglu EO, Ahiskalioglu A, Aydin P, Yayik AM, Temiz A. Effects of single-dose preemptive intravenous ibuprofen on postoperative opioid consumption and acute pain after laparoscopic cholecystectomy. Medicine (Baltimore). 2017 Feb;96(8):e6200. doi: 10.1097/MD.0000000000006200.
- Background Friedman BW, Dym AA, Davitt M, Holden L, Solorzano C, Esses D, Bijur PE, Gallagher EJ. Naproxen With Cyclobenzaprine, Oxycodone/Acetaminophen, or Placebo for Treating Acute Low Back Pain: A Randomized Clinical Trial. JAMA. 2015 Oct 20;314(15):1572-80. doi: 10.1001/jama.2015.13043.
- Background Gupta A, Abubaker H, Demas E, Ahrendtsen L. A Randomized Trial Comparing the Safety and Efficacy of Intravenous Ibuprofen versus Ibuprofen and Acetaminophen in Knee or Hip Arthroplasty. Pain Physician. 2016 Jul;19(6):349-56.
- Background Chang AK, Bijur PE, Esses D, Barnaby DP, Baer J. Effect of a Single Dose of Oral Opioid and Nonopioid Analgesics on Acute Extremity Pain in the Emergency Department: A Randomized Clinical Trial. JAMA. 2017 Nov 7;318(17):1661-1667. doi: 10.1001/jama.2017.16190.
- Background Krebs EE, Gravely A, Nugent S, Jensen AC, DeRonne B, Goldsmith ES, Kroenke K, Bair MJ, Noorbaloochi S. Effect of Opioid vs Nonopioid Medications on Pain-Related Function in Patients With Chronic Back Pain or Hip or Knee Osteoarthritis Pain: The SPACE Randomized Clinical Trial. JAMA. 2018 Mar 6;319(9):872-882. doi: 10.1001/jama.2018.0899.
- Background Thybo KH, Hagi-Pedersen D, Dahl JB, Wetterslev J, Nersesjan M, Jakobsen JC, Pedersen NA, Overgaard S, Schroder HM, Schmidt H, Bjorck JG, Skovmand K, Frederiksen R, Buus-Nielsen M, Sorensen CV, Kruuse LS, Lindholm P, Mathiesen O. Effect of Combination of Paracetamol (Acetaminophen) and Ibuprofen vs Either Alone on Patient-Controlled Morphine Consumption in the First 24 Hours After Total Hip Arthroplasty: The PANSAID Randomized Clinical Trial. JAMA. 2019 Feb 12;321(6):562-571. doi: 10.1001/jama.2018.22039.
- Background Derry S, Derry CJ, Moore RA. Single dose oral ibuprofen plus oxycodone for acute postoperative pain in adults. Cochrane Database Syst Rev. 2013 Jun 26;2013(6):CD010289. doi: 10.1002/14651858.CD010289.pub2.
- Background Cheung CW, Ching Wong SS, Qiu Q, Wang X. Oral Oxycodone for Acute Postoperative Pain: A Review of Clinical Trials. Pain Physician. 2017 Feb;20(2S):SE33-SE52.
- Background Feinberg AE, Chesney TR, Srikandarajah S, Acuna SA, McLeod RS; Best Practice in Surgery Group. Opioid Use After Discharge in Postoperative Patients: A Systematic Review. Ann Surg. 2018 Jun;267(6):1056-1062. doi: 10.1097/SLA.0000000000002591.
- Background Ladha KS, Neuman MD, Broms G, Bethell J, Bateman BT, Wijeysundera DN, Bell M, Hallqvist L, Svensson T, Newcomb CW, Brensinger CM, Gaskins LJ, Wunsch H. Opioid Prescribing After Surgery in the United States, Canada, and Sweden. JAMA Netw Open. 2019 Sep 4;2(9):e1910734. doi: 10.1001/jamanetworkopen.2019.10734.
- Background Hanson KT, Thiels CA, Polites SF, Gazelka HM, Ray-Zack MD, Zielinski MD, Habermann EB. The opioid epidemic in acute care surgery-Characteristics of overprescribing following laparoscopic cholecystectomy. J Trauma Acute Care Surg. 2018 Jul;85(1):62-70. doi: 10.1097/TA.0000000000001834.
- Background Hill MV, McMahon ML, Stucke RS, Barth RJ Jr. Wide Variation and Excessive Dosage of Opioid Prescriptions for Common General Surgical Procedures. Ann Surg. 2017 Apr;265(4):709-714. doi: 10.1097/SLA.0000000000001993.
- Background Michigan OPEN. Opioid Prescribing Recommendations for Opioid-Naive Patients. https://opioidprescribing.info. Published 2018. Accessed September 17, 2019.
- Background Sim V, Hawkins S, Gave AA, Bulanov A, Elabbasy F, Khoury L, Panzo M, Sim E, Cohn S. How low can you go: Achieving postoperative outpatient pain control without opioids. J Trauma Acute Care Surg. 2019 Jul;87(1):100-103. doi: 10.1097/TA.0000000000002295.
- Background Ayad S, Babazade R, Elsharkawy H, Nadar V, Lokhande C, Makarova N, Khanna R, Sessler DI, Turan A. Comparison of Transversus Abdominis Plane Infiltration with Liposomal Bupivacaine versus Continuous Epidural Analgesia versus Intravenous Opioid Analgesia. PLoS One. 2016 Apr 15;11(4):e0153675. doi: 10.1371/journal.pone.0153675. eCollection 2016.
- Background Turan A, Atim A, Dalton JE, Keeyapaj W, Chu W, Bernstein E, Fu A, Jae Ho L, Saager L, Sessler DI. Preoperative angiotensin-converting enzyme inhibitor use is not associated with increased postoperative pain and opioid use. Clin J Pain. 2013 Dec;29(12):1050-6. doi: 10.1097/AJP.0b013e318287a258.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ibuprofen | Small molecule | 600 mg | Oral |
| Comparator | Oxycodone | Other / unclassified | 5 mg | Oral |
Indications
No indication recorded.