Postoperative Pain Control With Fentanyl Patch in Patients Undergoing Mastectomy and TRAM or DIEP Flap Reconstruction

Phase 4

Completed

• Conditions: Postoperative Pain After Breast Reconstruction With Abdominal Flap
• Interventions: Drug: Inactive patch; Drug: Fentanyl

• Registration Number: NCT01258296
• Lead Sponsor: University of California, San Francisco

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-02
• Primary Completion: 2007-08
• Study Completion: 2007-08
• Status Verified: 2010-12
• Study First Submitted: 2010-12-09
• Study First Submitted QC: 2010-12-09
• Study First Posted: 2010-12-10
• Last Update Submitted: 2023-12-08
• Last Update Posted: 2023-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• Undergoing breast reconstruction with abdominal flap
• Provided written, informed consent

Exclusion Criteria

• Karnofsky performance status ≥80%

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo patch	Inactive patch	Inactive patch that resembles treatment patch but contains no drug
Active fentanyl patch	Fentanyl	25 mcg/hr fentanyl patch

Primary Outcome Measures

Name	Time	Method
Opioid analgesic use	10-20 days	Daily opioid use on immediate postoperative days while wearing patch

Secondary Outcome Measures

Name	Time	Method
Adverse event questionnaire	10-20 days	Daily measurement of headache, itching, nausea, vomiting, constipation, difficulty urinating, drowsiness, lightheadedness, indigestion
Functional assessment questionnaire	10-20 days	Daily measure of how surgical pain has interfered with general activity, mood, walking ability, sleep, brushing teeth, interactions with other people and enjoyment of life on a 0-10 scale on postoperative days
Pain intensity	10-20 days	Daily measure of pain intensity on 0-10 numeric rating scale on postoperative days
Relief from pain	10-20 days	Daily measure of relief provided by pain medications on 0-100% scale on postoperative days

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States