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

This study has been completed.
Sponsor:
Information provided by:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01258296
First received: December 9, 2010
Last updated: NA
Last verified: December 2010
History: No changes posted

December 9, 2010
December 9, 2010
February 2003
August 2007   (final data collection date for primary outcome measure)
Opioid analgesic use [ Time Frame: 10-20 days ] [ Designated as safety issue: No ]
Daily opioid use on immediate postoperative days while wearing patch
Same as current
No Changes Posted
  • Pain intensity [ Time Frame: 10-20 days ] [ Designated as safety issue: No ]
    Daily measure of pain intensity on 0-10 numeric rating scale on postoperative days
  • Relief from pain [ Time Frame: 10-20 days ] [ Designated as safety issue: No ]
    Daily measure of relief provided by pain medications on 0-100% scale on postoperative days
  • Adverse event questionnaire [ Time Frame: 10-20 days ] [ Designated as safety issue: Yes ]
    Daily measurement of headache, itching, nausea, vomiting, constipation, difficulty urinating, drowsiness, lightheadedness, indigestion
  • Functional assessment questionnaire [ Time Frame: 10-20 days ] [ Designated as safety issue: No ]
    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
Same as current
Not Provided
Not Provided
 
Postoperative Pain Control With Fentanyl Patch in Patients Undergoing Mastectomy and TRAM or DIEP Flap Reconstruction
Postoperative Pain Control With Fentanyl Patch in Patients Undergoing Mastectomy and TRAM or DIEP Flap Reconstruction

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Postoperative Pain After Breast Reconstruction With Abdominal Flap
  • Drug: Fentanyl
    25 mcg/hr transdermal patch
  • Drug: Inactive patch
    placebo patch (no drug)
  • Active Comparator: Active fentanyl patch
    25 mcg/hr fentanyl patch
    Intervention: Drug: Fentanyl
  • Placebo Comparator: Placebo patch
    Inactive patch that resembles treatment patch but contains no drug
    Intervention: Drug: Inactive patch
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
August 2007
August 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Karnofsky performance status ≥80%
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01258296
UCSF-04804
Yes
Laura Esserman, University of California, San Francisco
University of California, San Francisco
Not Provided
Principal Investigator: Laura Esserman, MD University of California, San Francisco
Study Director: Laura Petrillo, BA University of California, San Francisco
University of California, San Francisco
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP