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

NCT01258296 | Completed Phase 4 DMC

• 1 other identifier: UCSF-04804
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain After Breast Reconstruction With Abdominal Flap

Keywords

Postoperative pain; Breast reconstruction; Abdominal flap breast reconstruction

Outcome Measures

Primary Outcomes (1)

• Opioid analgesic use

  Daily opioid use on immediate postoperative days while wearing patch

  10-20 days

Secondary Outcomes (4)

• Pain intensity

  10-20 days

• Relief from pain

  10-20 days

• Adverse event questionnaire

  10-20 days

• Functional assessment questionnaire

  10-20 days

Study Arms (2)

Active fentanyl patch

ACTIVE COMPARATOR

25 mcg/hr fentanyl patch

Drug: Fentanyl

Placebo patch

PLACEBO COMPARATOR

Inactive patch that resembles treatment patch but contains no drug

Drug: Inactive patch

Interventions

Fentanyl DRUG

25 mcg/hr transdermal patch

Active fentanyl patch

Inactive patch DRUG

placebo patch (no drug)

Placebo patch

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Karnofsky performance status ≥80%

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Fentanyl

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Laura Esserman, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Laura Petrillo, BA

  University of California, San Francisco

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 9, 2010
• First Posted: December 10, 2010
• Study Start: February 1, 2003
• Primary Completion: August 1, 2007
• Study Completion: August 1, 2007
• Last Updated: December 12, 2023

Record last verified: 2010-12

Locations

US (1)