drugset / Trial / NCT07664956
Cyclobenzaprine for Postoperative Pain in Minimally Invasive Hysterectomy
RandomizedParallel-groupOpen-labelTreatment
Summary
Typical postoperative pain control after minimally invasive hysterectomy includes ibuprofen, acetaminophen, and a short course of narcotics. The purpose of this study is to see if adding cyclobenzaprine to this regime improves pain control and lessens narcotic use.
Timeline
- Start
- 2026-07-01
- Primary completion
- 2026-09-01
- Completion
- 2026-12-01
Publications
- Background Khan NF, Bykov K, Barnett ML, Glynn RJ, Vine SM, Gagne JJ. Comparative Risk of Opioid Overdose With Concomitant Use of Prescription Opioids and Skeletal Muscle Relaxants. Neurology. 2022 Sep 27;99(13):e1432-e1442. doi: 10.1212/WNL.0000000000200904. Epub 2022 Jul 14.
- Background Chen C, Hennessy S, Brensinger CM, Miano TA, Bilker WB, Dublin S, Chung SP, Horn JR, Tiwari A, Leonard CE. Comparative Risk of Injury with Concurrent Use of Opioids and Skeletal Muscle Relaxants. Clin Pharmacol Ther. 2024 Jul;116(1):117-127. doi: 10.1002/cpt.3248. Epub 2024 Mar 14.
- Background Day LT, Jeanmonod RK. Serotonin syndrome in a patient taking Lexapro and Flexeril: a case report. Am J Emerg Med. 2008 Nov;26(9):1069.e1-3. doi: 10.1016/j.ajem.2008.03.028.
- Background Braschi E, Garrison S, Allan GM. Cyclobenzaprine for acute back pain. Can Fam Physician. 2015 Dec;61(12):1074. No abstract available.
- Background Tu J, Zhang C, Xie S, He J, Zhang H. Cyclobenzaprine-related adverse events: a comprehensive pharmacovigilance analysis using the FDA Adverse Event Reporting System. Front Med (Lausanne). 2025 Sep 22;12:1574395. doi: 10.3389/fmed.2025.1574395. eCollection 2025.
- Background Choi JB, Kang K, Song MK, Seok S, Kim YH, Kim JE. Pain Characteristics after Total Laparoscopic Hysterectomy. Int J Med Sci. 2016 Jul 5;13(8):562-8. doi: 10.7150/ijms.15875. eCollection 2016.
- Background Nelson G, Altman AD, Nick A, Meyer LA, Ramirez PT, Achtari C, Antrobus J, Huang J, Scott M, Wijk L, Acheson N, Ljungqvist O, Dowdy SC. Guidelines for postoperative care in gynecologic/oncology surgery: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations--Part II. Gynecol Oncol. 2016 Feb;140(2):323-32. doi: 10.1016/j.ygyno.2015.12.019. Epub 2016 Jan 3. No abstract available.
- Background Turner NF, Greco NJ. The rapid recovery study: Cyclobenzaprine's effect on recovery following joint arthroplasty. J Orthop. 2024 Mar 13;54:81-85. doi: 10.1016/j.jor.2024.03.016. eCollection 2024 Aug.
- Background Ogura Y, Gum JL, Steele P, Crawford CH 3rd, Djurasovic M, Owens RK 2nd, Laratta JL, Davis E, Brown M, Daniels C, Dimar JR 2nd, Glassman SD, Carreon LY. Multi-modal pain control regimen for anterior lumbar fusion drastically reduces in-hospital opioid consumption. J Spine Surg. 2020 Dec;6(4):681-687. doi: 10.21037/jss-20-629.
- Background van Tulder MW, Touray T, Furlan AD, Solway S, Bouter LM; Cochrane Back Review Group. Muscle relaxants for nonspecific low back pain: a systematic review within the framework of the cochrane collaboration. Spine (Phila Pa 1976). 2003 Sep 1;28(17):1978-92. doi: 10.1097/01.BRS.0000090503.38830.AD.
- Background Winchell GA, King JD, Chavez-Eng CM, Constanzer ML, Korn SH. Cyclobenzaprine pharmacokinetics, including the effects of age, gender, and hepatic insufficiency. J Clin Pharmacol. 2002 Jan;42(1):61-9. doi: 10.1177/0091270002042001007.
- Background Verdiner R, Khurmi N, Choukalas C, Erickson C, Poterack K. Does adding muscle relaxant make post-operative pain better? a narrative review of the literature from US and European studies. Anesth Pain Med (Seoul). 2023 Oct;18(4):340-348. doi: 10.17085/apm.23055. Epub 2023 Oct 30.
- Background Farishta A, Iancau A, Janis JE, Joshi GP. Use of Muscle Relaxants for Acute Postoperative Pain: A Practical Review. Plast Reconstr Surg Glob Open. 2024 Jul 1;12(7):e5938. doi: 10.1097/GOX.0000000000005938. eCollection 2024 Jul.
- Background Ayogu CI, Javed A, Pompeu Dos Santos AF. Enhanced Recovery After Surgery vs Traditional Recovery Pathway After Minimally Invasive Hysterectomy for Benign Indications: A Systematic Review and Meta-Analysis. J Minim Invasive Gynecol. 2025 Sep;32(9):775-783. doi: 10.1016/j.jmig.2025.04.003. Epub 2025 Apr 10.
- Background Wang Y, Sun J, Yu K, Liu X, Liu L, Miao H, Li T. Virtual reality exposure reduce acute postoperative pain in female patients undergoing laparoscopic gynecology surgery: A Randomized Control Trial (RCT) study. J Clin Anesth. 2024 Oct;97:111525. doi: 10.1016/j.jclinane.2024.111525. Epub 2024 Jun 12.
- Background Huda AU, Minhas R, Yasir M. Intravenous ketamine in gynaecological surgeries reduces pain score and opioid consumption. J Pak Med Assoc. 2022 Dec;72(12):2491-2497. doi: 10.47391/JPMA.5275.
- Background Somaini M, Brambillasca P, Ingelmo PM, Lovisari F, Catenacci SS, Rossini V, Bucciero M, Sahillioglu E, Buda A, Signorelli M, Gili M, Joshi G, Fumagalli R, Ferland CE, Diemunsch P. Effects of peritoneal ropivacaine nebulization for pain control after laparoscopic gynecologic surgery. J Minim Invasive Gynecol. 2014 Sep-Oct;21(5):863-9. doi: 10.1016/j.jmig.2014.03.021. Epub 2014 Apr 12.
- Background Blanton E, Lamvu G, Patanwala I, Barron KI, Witzeman K, Tu FF, As-Sanie S. Non-opioid pain management in benign minimally invasive hysterectomy: A systematic review. Am J Obstet Gynecol. 2017 Jun;216(6):557-567. doi: 10.1016/j.ajog.2016.12.175. Epub 2016 Dec 30.
- Background Wong M, Morris S, Wang K, Simpson K. Managing Postoperative Pain After Minimally Invasive Gynecologic Surgery in the Era of the Opioid Epidemic. J Minim Invasive Gynecol. 2018 Nov-Dec;25(7):1165-1178. doi: 10.1016/j.jmig.2017.09.016. Epub 2017 Sep 28.
- Background Munro A, Sjaus A, George RB. Anesthesia and analgesia for gynecological surgery. Curr Opin Anaesthesiol. 2018 Jun;31(3):274-279. doi: 10.1097/ACO.0000000000000584.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | cyclobenzaprine | Small molecule | 5 mg | — |