Clinical trial · Interventional
Cyclobenzaprine for Postoperative Pain in Minimally Invasive Hysterectomy
Cyclobenzaprine for Postoperative Pain in Minimally Invasive Hysterectomy: A Randomized Controlled Trial
NCT07664956CI-TRIAL-00115708not yet recruitingPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Abnormal Uterine Bleeding, Unspecified | — | UNRESOLVED | — |
| Adenomyosis of Uterus | — | UNRESOLVED | — |
| Adnexal Diseases | — | UNRESOLVED | — |
| Chronic Pelvic Pain | — | UNRESOLVED | — |
| Endometriosis | — | UNRESOLVED | — |
| Endometritis | — | UNRESOLVED | — |
| Fibroid Uterus | Uterine Corpus Leiomyoma | ALIAS | 0.90 |
| Menorrhagia | — | UNRESOLVED | — |
| Minimally Invasive Surgical Procedures | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclobenzaprine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Control
- description
- No additional intervention
- type
- EXPERIMENTAL
- label
- Cyclobenzaprine
- description
- 5mg cyclobenzaprine q8h for one week postoperatively
- interventionNames
- Drug: Cyclobenzaprine
Primary outcomes (1)
- measure
- Visual Analog Scale (VAS) Pain Score on Post Op Day 3
- timeFrame
- 3 days postoperatively
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \>18yo * Female * English speaking * Undergoing (robotic assisted or classic) total laparoscopic hysterectomy ± unilateral or bilateral salpingectomy ± unilateral or bilateral oophorectomy * If other procedures such as lysis of adhesions, excision of endometriosis, or ureterolysis are indicated based on intraoperative evaluation, those patients may still be included * Surgery took place at ChristianaCare Hospitals * No allergies or contraindications to standard of care post operative pain medications (acetaminophen, NSAIDs, narcotics) or cyclobenzaprine Exclusion Criteria: * Age \<18yo * Male * Pregnant, breastfeeding * Non-English speaking * Primary procedures other than laparoscopic hysterectomy * Laparoscopic myomectomy * Laparoscopic resection of endometriosis * Laparoscopic unilateral or bilateral salpingectomy ± unilateral or bilateral oophorectomy ± unilateral or bilateral cystectomy without hysterectomy * Hysteroscopic procedures * Bartholin gland marsupialization * Operations that are scheduled as or converted to the open approach * Procedures with planned or unplanned bladder or bowel surgery * Allergies or contraindications to standard post operative pain control medications (acetaminophen, NSAIDs, narcotics), such as kidney or liver damage/failure, bariatric surgery, history of gastric ulcer, etc. * Chronic pain issues, whether self-diagnosed or by a physician, currently undergoing management * Currently undergoing medication assisted treatment for opioid use disorder * Currently using opioids consistently * Allergies or contraindications to cyclobenzaprine: * Absolute: use of MAO inhibitors within 14 days, recent heart attack, congestive heart failure, heart block or other conduction abnormalities, cardiac arrhythmias, hyperthyroidism, history of serotonin syndrome * Allergies or contraindications to inactive ingredients in Flexeril, such as lactose * Patient's receiving gabapentin at baseline or postoperatively, due to potential sedating effects, or other sedating drugs such as scheduled benzodiazepines and barbiturates
References
Publications (20)
- BACKGROUNDKhan 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. PMID 35835561
- BACKGROUNDChen 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. PMID 38482733
- BACKGROUNDDay 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. PMID 19091289
- BACKGROUNDBraschi E, Garrison S, Allan GM. Cyclobenzaprine for acute back pain. Can Fam Physician. 2015 Dec;61(12):1074. No abstract available. PMID 26668287
- BACKGROUNDTu 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. PMID 41058614
- BACKGROUNDChoi 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. PMID 27499688
- BACKGROUNDNelson 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.