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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01258296
Recruitment Status : Completed
First Posted : December 10, 2010
Last Update Posted : December 10, 2010
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Postoperative Pain After Breast Reconstruction With Abdominal Flap Drug: Fentanyl Drug: Inactive patch Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Postoperative Pain Control With Fentanyl Patch in Patients Undergoing Mastectomy and TRAM or DIEP Flap Reconstruction
Study Start Date : February 2003
Actual Primary Completion Date : August 2007
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Active fentanyl patch
25 mcg/hr fentanyl patch
Drug: Fentanyl
25 mcg/hr transdermal patch

Placebo Comparator: Placebo patch
Inactive patch that resembles treatment patch but contains no drug
Drug: Inactive patch
placebo patch (no drug)

Primary Outcome Measures :
  1. Opioid analgesic use [ Time Frame: 10-20 days ]
    Daily opioid use on immediate postoperative days while wearing patch

Secondary Outcome Measures :
  1. Pain intensity [ Time Frame: 10-20 days ]
    Daily measure of pain intensity on 0-10 numeric rating scale on postoperative days

  2. Relief from pain [ Time Frame: 10-20 days ]
    Daily measure of relief provided by pain medications on 0-100% scale on postoperative days

  3. Adverse event questionnaire [ Time Frame: 10-20 days ]
    Daily measurement of headache, itching, nausea, vomiting, constipation, difficulty urinating, drowsiness, lightheadedness, indigestion

  4. Functional assessment questionnaire [ Time Frame: 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

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • Karnofsky performance status ≥80%

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01258296

United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Principal Investigator: Laura Esserman, MD University of California, San Francisco
Study Director: Laura Petrillo, BA University of California, San Francisco

Responsible Party: Laura Esserman, University of California, San Francisco Identifier: NCT01258296     History of Changes
Other Study ID Numbers: UCSF-04804
First Posted: December 10, 2010    Key Record Dates
Last Update Posted: December 10, 2010
Last Verified: December 2010

Keywords provided by University of California, San Francisco:
Postoperative pain
Breast reconstruction
Abdominal flap breast reconstruction

Additional relevant MeSH terms:
Pain, Postoperative
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General