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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
  Purpose

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 Intervention Phase
Postoperative Pain After Breast Reconstruction With Abdominal Flap
 Drug: Fentanyl
Drug: Inactive patch
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Postoperative Pain Control With Fentanyl Patch in Patients Undergoing Mastectomy and TRAM or DIEP Flap Reconstruction

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Opioid analgesic use [ Time Frame: 10-20 days ] [ Designated as safety issue: No ]
    Daily opioid use on immediate postoperative days while wearing patch


Secondary Outcome Measures:
  • 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


Enrollment: 60
Study Start Date: February 2003
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Karnofsky performance status ≥80%
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01258296

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

No publications provided

Responsible Party: Laura Esserman, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01258296     History of Changes
Other Study ID Numbers: UCSF-04804
Study First Received: December 9, 2010
Last Updated: December 9, 2010
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Fentanyl
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
 Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid

ClinicalTrials.gov processed this record on May 19, 2013