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NCT Number: NCT07664956

Cyclobenzaprine for Postoperative Pain in Minimally Invasive Hysterectomy

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cyclobenzaprine

Drug

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

Primary outcomes

  1. Visual Analog Scale (VAS) Pain Score on Post Op Day 3

    Time frame: 3 days postoperatively

    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.

Secondary outcomes

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

    Time frame: 1 week

    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.

  2. Cyclobenzaprine Side Effects as Part of Multimodal Analgesia

    Time frame: 1 week

    The study will collect data on and analyze and describe side effects that may be contributed to cyclobenzaprine use.

  3. Potential Contributors to Differences in Visual Analog Pain Scale Reported

    Time frame: 1 week

    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.

  4. Number of Alternative Postoperative Pain Medications Required to Achieve Adequate Analgesia

    Time frame: 1 week

    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.

Other outcomes

  1. Changes in Number of Interactions with the Health System

    Time frame: 4 weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kathryn Denny, MD

CONTACT

Margaret Wingo, MD

CONTACT

[email protected]

302-623-4410

Sponsors and collaborators

Lead sponsor

Christiana Care Health Services

Other

Registry information

Official study title

Cyclobenzaprine for Postoperative Pain in Minimally Invasive Hysterectomy: A Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 24, 2026
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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