Cyclobenzaprine for Postoperative Pain in Minimally Invasive Hysterectomy

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18+
SponsorChristiana Care Health Services

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Cyclobenzaprine

    Drug

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

Treatment groups

36 Participants
are divided into 2 treatment groups
Group A: ControlNo intervention 0 interventions
Group B: CyclobenzaprineExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
3 days postoperatively

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

1

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

Sponsors and contacts

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