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

Tracking Information

First Received Date ^ICMJE

December 9, 2010

Last Updated Date

December 9, 2010

Start Date ^ICMJE

February 2003

Primary Completion Date

August 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Opioid analgesic use [ Time Frame: 10-20 days ] [ Designated as safety issue: No ]

Daily opioid use on immediate postoperative days while wearing patch

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Postoperative Pain After Breast Reconstruction With Abdominal Flap

Intervention ^ICMJE

Drug: Fentanyl
25 mcg/hr transdermal patch
Drug: Inactive patch
placebo patch (no drug)

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

August 2007

Primary Completion Date

August 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Undergoing breast reconstruction with abdominal flap
Provided written, informed consent

Exclusion Criteria:

Karnofsky performance status ≥80%

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01258296

Other Study ID Numbers ^ICMJE

UCSF-04804

Has Data Monitoring Committee

Yes

Responsible Party

Laura Esserman, University of California, San Francisco

Study Sponsor ^ICMJE

University of California, San Francisco

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:	Laura Esserman, MD	University of California, San Francisco
Study Director:	Laura Petrillo, BA	University of California, San Francisco

Information Provided By

University of California, San Francisco

Verification Date

December 2010

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

To Top