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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
25 mcg/hr transdermal patch
placebo patch (no drug)
University of California, San Francisco
San Francisco, California, United States
Opioid analgesic use
Daily opioid use on immediate postoperative days while wearing patch
Time frame: 10-20 days
Pain intensity
Daily measure of pain intensity on 0-10 numeric rating scale on postoperative days
Time frame: 10-20 days
Relief from pain
Daily measure of relief provided by pain medications on 0-100% scale on postoperative days
Time frame: 10-20 days
Adverse event questionnaire
Daily measurement of headache, itching, nausea, vomiting, constipation, difficulty urinating, drowsiness, lightheadedness, indigestion
Time frame: 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
Time frame: 10-20 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.