Postoperative Pain Control With Fentanyl Patch in Patients Undergoing Mastectomy and TRAM or DIEP Flap Reconstruction
Status:
Completed
Trial end date:
2007-08-01
Target enrollment:
Participant gender:
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.