Postoperative Pain Control With Fentanyl Patch in Patients Undergoing Mastectomy and TRAM or DIEP Flap Reconstruction
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Opioid analgesic use
Study Overview
Brief Summary
The aim of this randomized, double-blind controlled trial is to determine the efficacy of transdermal fentanyl for the management of early postoperative pain in women undergoing mastectomy followed by immediate TRAM or DIEP flap reconstruction. We will examine whether the use of the fentanyl patch as a bridge between epidural and oral analgesia will improve overall pain relief compared to placebo patch. We further propose to study whether the fentanyl patch is associated with improved ability to sleep, patient satisfaction, and functional capacity at one week, and whether it is associated with different side effects than standard therapy without the patch. Following informed consent, patients will undergo mastectomy and reconstruction, and receive epidural fentanyl for initial postoperative analgesia. Patients will be randomized to active (25 mcg/hr Duragesic) or placebo patches on postoperative day three, and the epidural will be weaned over the next 12 hours. Pain intensity scores and relief from pain will be assessed every day while in the hospital and oral and IV opioid use recorded. Patients will be discharged to home with a supply of 2 patches and oral medication, and will be asked to fill out a daily pain and medication log.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Undergoing breast reconstruction with abdominal flap
- •Provided written, informed consent
Exclusion Criteria
- •Karnofsky performance status ≥80%
Arms & Interventions
Active fentanyl patch
25 mcg/hr fentanyl patch
Intervention: Fentanyl (Drug)
Placebo patch
Inactive patch that resembles treatment patch but contains no drug
Intervention: Inactive patch (Drug)
Outcomes
Primary Outcomes
Opioid analgesic use
Time Frame: 10-20 days
Daily opioid use on immediate postoperative days while wearing patch
Secondary Outcomes
- Adverse event questionnaire(10-20 days)
- Functional assessment questionnaire(10-20 days)
- Pain intensity(10-20 days)
- Relief from pain(10-20 days)