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NCT04278846 · ClinicalTrials.gov registry record · Phase 4
Efficacy of Liposomal Bupivacaine for Prolonged Postoperative Analgesia in Patient Undergoing Breast Reconstruction With Tissue Expander
A Phase 4 study, sponsored by The Cleveland Clinic.
- Completed
- Registry status
- Phase 4
- Development phase
- 50
- Enrollment target
NCT04278846: Completed Phase 4 study, sponsored by The Cleveland Clinic.
NCT04278846 is a Phase 4 study that has completed, run by The Cleveland Clinic. The registered enrollment target is 50 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04278846, a Phase 4 study, has completed, sponsored by The Cleveland Clinic.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 50 participants
- Enrollment target
Study Summary
Patients undergoing breast reconstruction with tissue expanders will be treated with a local anesthetic during their procedure and monitor their post-operative pain level and amount of oral pain medication taken. This information will be used to determine if liposomal bupivacaine provides better and longer pain control vs. bupivacaine HCl.
Primary Outcome
Pain will be assessed qualitatively through the use of numeric rating scale (0-10) during rest (NRS-R) Scale name: Numeric rating scale during rest (NRS-R) The higher scores indicate more severe pain during rest (10 meaning the worst pain, 0 meaning no pain)
Interventions
- DRUG Depofoam bupivacaine
- DRUG Bupivacaine hydrochloride (HCl)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2014-08-22 |
| Est. Completion | 2019-05-15 |
| Phase | Phase 4 |
What the finished NCT04278846 record still lists
NCT04278846 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 2 interventions - of which Depofoam bupivacaine is the first listed.
NCT04278846 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04278846 about?
NCT04278846 is a clinical study titled "Efficacy of Liposomal Bupivacaine for Prolonged Postoperative Analgesia in Patient Undergoing Breast Reconstruction With Tissue Expander". Patients undergoing breast reconstruction with tissue expanders will be treated with a local anesthetic during their procedure and monitor their post-operative pain level and amount of oral pain medication taken. This information will be used to determine if liposomal bupivacaine provides better and...
What is the current status of trial NCT04278846?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 50 participants. The study started on 2014-08-22. Estimated completion is 2019-05-15.
What interventions are being tested in trial NCT04278846?
The interventions under investigation include: Depofoam bupivacaine (DRUG), Bupivacaine hydrochloride (HCl) (DRUG).
Who is sponsoring clinical trial NCT04278846?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04278846's enrollment target sits among peer trials
50 1255th of 2000 higher than 678 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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