A Phase 4 interventional study of Cyclobenzaprine in Minimally Invasive Surgical Procedures, Abnormal Uterine Bleeding, Unspecified and Adenomyosis of Uterus, sponsored by Christiana Care Health Services. Not yet recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-24.
Sponsored by Christiana Care Health Services · Phase 4, Interventional, and Treatment
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.
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.
153 studies on the registry are indexed under Metrorrhagia; 35 are open to participants now.
This study's planned enrollment of 36 is below the median of 100 across 115 interventional studies indexed under Metrorrhagia.
Browse Metrorrhagia studies →Christiana Care Health Services is the lead sponsor of 94 studies on the registry; 6 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
No additional intervention
5mg cyclobenzaprine q8h for one week postoperatively
Drug: Cyclobenzaprine
5mg cyclobenzaprine q8hr for one week postoperatively after minimally invasive hysterectomy
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.
Time frame: 3 days postoperatively
Visual Analog Scale (VAS) Pain Scores on POD 0, 1, and 7
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.
Time frame: 1 week
Cyclobenzaprine Side Effects as Part of Multimodal Analgesia
The study will collect data on and analyze and describe side effects that may be contributed to cyclobenzaprine use.
Time frame: 1 week
Potential Contributors to Differences in Visual Analog Pain Scale Reported
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.
Time frame: 1 week
Number of Alternative Postoperative Pain Medications Required to Achieve Adequate Analgesia
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.
Time frame: 1 week
Changes in Number of Interactions with the Health System
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.
Time frame: 4 weeks
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — Individual data will not be analyzed, only group data.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Cyclobenzaprine
Christiana Care Health Services