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OpenTrials
Completed

NCT Number: NCT01258296

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

University of California, San Francisco

San Francisco, California, 94143, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Karnofsky performance status ≥80%

Treatment and study plan

Fentanyl

Drug

25 mcg/hr transdermal patch

Inactive patch

Drug

placebo patch (no drug)

Primary outcomes

  1. Opioid analgesic use

    Time frame: 10-20 days

    Daily opioid use on immediate postoperative days while wearing patch

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Acronym: Fentanyl Patch

Important dates

Study start
2003
Primary completion
2007
Study completion
2007
First posted
Dec 10, 2010
Registry last updated
Dec 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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