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NCT01258296 · ClinicalTrials.gov registry record · Phase 4
Postoperative Pain Control With Fentanyl Patch in Patients Undergoing Mastectomy and TRAM or DIEP Flap Reconstruction
A Phase 4 study, sponsored by University of California, San Francisco.
- Completed
- Registry status
- Phase 4
- Development phase
- 60
- Enrollment target
NCT01258296: Completed Phase 4 study, sponsored by University of California, San Francisco.
NCT01258296 is a Phase 4 study that has completed, run by University of California, San Francisco. The registered enrollment target is 60 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01258296, a Phase 4 study, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 60 participants
- Enrollment target
Study 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.
Primary Outcome
Daily opioid use on immediate postoperative days while wearing patch
Interventions
- DRUG Fentanyl
- DRUG Inactive patch
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2003-02 |
| Est. Completion | 2007-08 |
| Phase | Phase 4 |
What the finished NCT01258296 record still lists
NCT01258296 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 2 interventions - of which Fentanyl is the first listed.
NCT01258296 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01258296 about?
NCT01258296 is a clinical study titled "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 a...
What is the current status of trial NCT01258296?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 60 participants. The study started on 2003-02. Estimated completion is 2007-08.
What interventions are being tested in trial NCT01258296?
The interventions under investigation include: Fentanyl (DRUG), Inactive patch (DRUG).
Who is sponsoring clinical trial NCT01258296?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01258296's enrollment target sits among peer trials
60 1125th of 2000 higher than 799 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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