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

Study Overview
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Brief Summary
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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.

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

Conditions
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Postoperative Pain After Breast Reconstruction With Abdominal Flap

Intervention / Treatment
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* Drug: Fentanyl
* Drug: Inactive patch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Undergoing breast reconstruction with abdominal flap Provided written, informed consent Exclusion Criteria: Karnofsky performance status ≥80%

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active fentanyl patch<br>25 mcg/hr fentanyl patch | Drug: Fentanyl<br>* 25 mcg/hr transdermal patch<br>|
| Placebo Comparator: Placebo patch<br>Inactive patch that resembles treatment patch but contains no drug | Drug: Inactive patch<br>* placebo patch (no drug)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid analgesic use | Daily opioid use on immediate postoperative days while wearing patch | 10-20 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity | Daily measure of pain intensity on 0-10 numeric rating scale on postoperative days | 10-20 days | 
| Relief from pain | Daily measure of relief provided by pain medications on 0-100% scale on postoperative days | 10-20 days | 
| Adverse event questionnaire | Daily measurement of headache, itching, nausea, vomiting, constipation, difficulty urinating, drowsiness, lightheadedness, indigestion | 10-20 days | 
| Functional assessment questionnaire | 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 | 10-20 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postoperative pain, Breast reconstruction, Abdominal flap breast reconstruction