Cyclobenzaprine for Postoperative Pain in Minimally Invasive Hysterectomy
Starting soon · Phase 4
Conditions studied: Minimally Invasive Surgical Procedures, Abnormal Uterine Bleeding, Unspecified, Adenomyosis of Uterus, Fibroid Uterus, Chronic Pelvic Pain, Endometriosis, Menorrhagia, Endometritis, Adnexal Diseases
In brief
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.
Key facts
- Study ID
- NCT07664956
- Run by
- Christiana Care Health Services
- People needed
- 36
- Starts
- 2026-07-01
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2026-06-24
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- ChristianaCare Health System — Newark, Delaware, United States
Full record on ClinicalTrials.gov
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