Cyclobenzaprine for Postoperative Pain in Minimally Invasive Hysterectomy

NCT07664956 | Not Yet Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 50092
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Minimally Invasive Surgical Procedures; Abnormal Uterine Bleeding, Unspecified; Adenomyosis of Uterus; Fibroid Uterus; Chronic Pelvic Pain; Endometriosis; Menorrhagia; Endometritis; Adnexal Diseases

Keywords

cyclobenzaprine; flexeril; hysterectomy; minimally invasive hysterectomy; pain control; multimodal pain control

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Visual Analog Scale (VAS) Pain Scores on POD 0, 1, and 7

  1 week

• Cyclobenzaprine Side Effects as Part of Multimodal Analgesia

  1 week

• Potential Contributors to Differences in Visual Analog Pain Scale Reported

  1 week

• Number of Alternative Postoperative Pain Medications Required to Achieve Adequate Analgesia

  1 week

Other Outcomes (1)

• Changes in Number of Interactions with the Health System

  4 weeks

Study Arms (2)

Control

NO INTERVENTION

No additional intervention

Cyclobenzaprine

EXPERIMENTAL

5mg cyclobenzaprine q8h for one week postoperatively

Drug: Cyclobenzaprine

Interventions

Cyclobenzaprine DRUG

5mg cyclobenzaprine q8hr for one week postoperatively after minimally invasive hysterectomy

Cyclobenzaprine

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Christiana Care Health Services: lead

Study Sites (1)

ChristianaCare Health System

Newark, Delaware, 19718, United States

Location

Related Publications (20)

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Related Links

• Cyclobenzaprine PubChem
• Cyclobenzaprine StatPearls
• Cyclobenzaprine FDA Label

MeSH Terms

Conditions

Metrorrhagia; Adenomyosis; Leiomyoma; Endometriosis; Menorrhagia; Endometritis; Adnexal Diseases; Agnosia

Interventions

cyclobenzaprine

Condition Hierarchy (Ancestors)

Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Menstruation Disturbances; Pelvic Inflammatory Disease; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Central Study Contacts

Margaret Wingo, MD

CONTACT

302-623-4410; margaret.wingo@christianacare.org

Kathryn Denny, MD

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2026
• First Posted: June 24, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 24, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)