search
Back to results

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

Primary Purpose

Postoperative Pain After Breast Reconstruction With Abdominal Flap

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Fentanyl
Inactive patch
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain After Breast Reconstruction With Abdominal Flap focused on measuring Postoperative pain, Breast reconstruction, Abdominal flap breast reconstruction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Karnofsky performance status ≥80%

Sites / Locations

  • University of California, San Francisco

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Active fentanyl patch

Placebo patch

Arm Description

25 mcg/hr fentanyl patch

Inactive patch that resembles treatment patch but contains no drug

Outcomes

Primary Outcome Measures

Opioid analgesic use
Daily opioid use on immediate postoperative days while wearing patch

Secondary Outcome Measures

Pain intensity
Daily measure of pain intensity on 0-10 numeric rating scale on postoperative days
Relief from pain
Daily measure of relief provided by pain medications on 0-100% scale on postoperative days
Adverse event questionnaire
Daily measurement of headache, itching, nausea, vomiting, constipation, difficulty urinating, drowsiness, lightheadedness, indigestion
Functional assessment questionnaire
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

Full Information

First Posted
December 9, 2010
Last Updated
December 9, 2010
Sponsor
University of California, San Francisco
search

1. Study Identification

Unique Protocol Identification Number
NCT01258296
Brief Title
Postoperative Pain Control With Fentanyl Patch in Patients Undergoing Mastectomy and TRAM or DIEP Flap Reconstruction
Acronym
Fentanyl Patch
Official Title
Postoperative Pain Control With Fentanyl Patch in Patients Undergoing Mastectomy and TRAM or DIEP Flap Reconstruction
Study Type
Interventional

2. Study Status

Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
February 2003 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
August 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of California, San Francisco

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain After Breast Reconstruction With Abdominal Flap
Keywords
Postoperative pain, Breast reconstruction, Abdominal flap breast reconstruction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active fentanyl patch
Arm Type
Active Comparator
Arm Description
25 mcg/hr fentanyl patch
Arm Title
Placebo patch
Arm Type
Placebo Comparator
Arm Description
Inactive patch that resembles treatment patch but contains no drug
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Intervention Description
25 mcg/hr transdermal patch
Intervention Type
Drug
Intervention Name(s)
Inactive patch
Intervention Description
placebo patch (no drug)
Primary Outcome Measure Information:
Title
Opioid analgesic use
Description
Daily opioid use on immediate postoperative days while wearing patch
Time Frame
10-20 days
Secondary Outcome Measure Information:
Title
Pain intensity
Description
Daily measure of pain intensity on 0-10 numeric rating scale on postoperative days
Time Frame
10-20 days
Title
Relief from pain
Description
Daily measure of relief provided by pain medications on 0-100% scale on postoperative days
Time Frame
10-20 days
Title
Adverse event questionnaire
Description
Daily measurement of headache, itching, nausea, vomiting, constipation, difficulty urinating, drowsiness, lightheadedness, indigestion
Time Frame
10-20 days
Title
Functional assessment questionnaire
Description
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
Time Frame
10-20 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Undergoing breast reconstruction with abdominal flap Provided written, informed consent Exclusion Criteria: Karnofsky performance status ≥80%
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Esserman, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Laura Petrillo, BA
Organizational Affiliation
University of California, San Francisco
Official's Role
Study Director
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs