Cyclobenzaprine for Postoperative Pain in Minimally Invasive Hysterectomy
NCT07664956
· ctgov
not_yet_recruiting
phase phase-4
- Enrollment
- 36
- Start
- 2026-07-01
- Completion
- 2026-12-01
- Last updated
- 2026-06-24
- Has results
- False
- Countries
- United States
Conditions
Tagged with
Interventions
-
Cyclobenzaprine
DRUG
5mg cyclobenzaprine q8hr for one week postoperatively after minimally invasive hysterectomy
Eligibility criteria
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
License: public-domain-us
· commercial use OK
· attribution required
Courtesy of ClinicalTrials.gov / U.S. National Library of Medicine
Courtesy of ClinicalTrials.gov / U.S. National Library of Medicine