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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.
The purpose of this study is to gather more information on cyclobenzaprine as part of postoperative pain control. Cyclobenzaprine, aka Flexeril®, is NOT an experimental drug and is already approved by the Food and Drug Administration (FDA) for acute, painful muscle spasms. It is commonly used for muscle-related pain disorders.
This research is being done because prior studies have shown that cyclobenzaprine helps with pain due to muscle spasms. Some studies showed that cyclobenzaprine does help reduce pain scores in patients undergoing abdominal or joint surgery, but the studies are very limited. This study will see if cyclobenzaprine can be used to decrease post-operative pain in patients undergoing minimally invasive hysterectomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | No additional intervention | |
| Cyclobenzaprine | Experimental | 5mg cyclobenzaprine q8h for one week postoperatively |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cyclobenzaprine | Drug | 5mg cyclobenzaprine q8hr for one week postoperatively after minimally invasive hysterectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale (VAS) Pain Score on Post Op Day 3 | The primary objective of the study will be to assess pain scores via Visual Analog Scale (VAS) on Post Op Day 3 compared between the control group vs cyclobenzaprine group. Ratings will be from 0 to 10, which are associated with visual cues to aid in selection. As stated above, VAS pain scores will be collected electronically via REDCap. The survey will be distributed via Doximity text or patient portal message. | 3 days postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale (VAS) Pain Scores on POD 0, 1, and 7 | Visual Analog Scale (VAS) is rated 0-10. The study is not designed, nor powered, to test any other hypotheses other than the primary outcome. However, the study will collect data on analgesic use over a one-week period. In addition to the primary outcome of pain scores on POD3, pain scores will be collected on post op days 0, 1, and 7. | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Number of Interactions with the Health System | The researchers will determine if having the addition of cyclobenzaprine as part of postoperative multimodal pain management correlates with the number of times the patient interacts with the health system postoperatively, including but not limited to communications, office visits, ER visits, and readmissions. | 4 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Margaret Wingo, MD | Contact | 302-623-4410 | margaret.wingo@christianacare.org | |
| Kathryn Denny, MD | Contact |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ChristianaCare Health System | Newark | Delaware | 19718 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35835561 | 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. | |
| 38482733 | 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. |
| Label | URL |
|---|---|
| Cyclobenzaprine DrugBank | View source |
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Individual data will not be analyzed, only group data.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 10, 2026 |
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| Cyclobenzaprine Side Effects as Part of Multimodal Analgesia | The study will collect data on and analyze and describe side effects that may be contributed to cyclobenzaprine use. | 1 week |
| Potential Contributors to Differences in Visual Analog Pain Scale Reported | The researchers will also collect data to determine if any of the following variables contribute to changes in pain scores and/or requirements for analgesia: size of uterus, indication for operation, pathology, length of operation, blood loss, complications, and other pelvic surgeries performed. | 1 week |
| Number of Alternative Postoperative Pain Medications Required to Achieve Adequate Analgesia | The researchers will determine if adding another adjunctive medication (i.e. cyclobenzaprine) for pain affects the compliance of post-operative medications (such as ibuprofen, acetaminophen, and oxycodone). Specifically, we will determine the number of oxycodone tabs left at the end of the first week postoperatively and ask the patient to report if they took ibuprofen and acetaminophen scheduled, as prescribed. | 1 week |
| 19091289 | 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. |
| 26668287 | Background | Braschi E, Garrison S, Allan GM. Cyclobenzaprine for acute back pain. Can Fam Physician. 2015 Dec;61(12):1074. No abstract available. |
| 41058614 | 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. |
| 27499688 | 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. |
| 26757238 | 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. |
| 38550387 | 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. |
| 33447670 | 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. |
| 12973146 | 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. |
| 11808825 | 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. |
| 37919918 | 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. |
| 38957722 | 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. |
| 40216301 | 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. |
| 38870701 | 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. |
| 37246675 | 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. |
| 24727030 | 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. |
| 28043841 | 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. |
| 28964926 | 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. |
| 29474216 | 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. |
| Cyclobenzaprine PubChem | View source |
| Cyclobenzaprine StatPearls | View source |
| Cyclobenzaprine FDA Label | View source |
| Apr 10, 2026 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 10, 2026 | May 18, 2026 | ICF_001.pdf |
| ID | Term |
|---|---|
| D008796 | Metrorrhagia |
| D062788 | Adenomyosis |
| D007889 | Leiomyoma |
| D004715 | Endometriosis |
| D008595 | Menorrhagia |
| D004716 | Endometritis |
| D000291 | Adnexal Diseases |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D014592 | Uterine Hemorrhage |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008599 | Menstruation Disturbances |
| D000292 | Pelvic Inflammatory Disease |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| C004704 | cyclobenzaprine |
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