About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age >18yo
Female
English speaking
Undergoing (robotic assisted or classic) total laparoscopic hysterectomy ± unilateral or bilateral salpingectomy ± unilateral or bilateral oophorectomy
Disqualifiers
Age <18yo
Male
Pregnant, breastfeeding
Non-English speaking
Trial design
Parallel
Treatments tested in this trial
Cyclobenzaprine
Drug5mg cyclobenzaprine q8hr for one week postoperatively after minimally invasive hysterectomy
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
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.
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.
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.
Other outcomes
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.
Sponsors and contacts
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