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NCT04603911 · ClinicalTrials.gov registry record · Phase 2
RCT Comparing ESPB Solutions in Breast Surgery
A Phase 2 study, sponsored by Tufts Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 75
- Enrollment target
NCT04603911: Completed Phase 2 study, sponsored by Tufts Medical Center.
NCT04603911 is a Phase 2 study that has completed, run by Tufts Medical Center. The registered enrollment target is 75 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (44% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04603911, a Phase 2 study, has completed, sponsored by Tufts Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 75 participants
- Enrollment target
Study Summary
The object of our research is to investigate the relative efficacy of liposomal bupivacaine administered via an Erector Spinae Plane (ESP) block as compared to our standard of care medication solution of (bupivacaine mixed with epinephrine, dexamethasone, and clonidine) for pain management in subjects undergoing bilateral surgical intervention for breast cancer. This will be an investigator-initiated, double-blind, patient-controlled, randomized control trial comparing pain scores at 48 hours after injection.
Primary Outcome
Pain score will be recorded using a visual analogue scale (VAS) where 0 is no pain and 10 is unbearable pain. Pain will be recorded for the right and left side independently.
Interventions
- DRUG Liposomal bupivacaine
- DRUG Bupivacaine, epinephrine, dexamethasone, and clonidine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2020-12-04 |
| Est. Completion | 2023-04-10 |
| Phase | Phase 2 |
What the finished NCT04603911 record still lists
NCT04603911 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (44% lower).
The record links to 0 conditions, and to 2 interventions - of which Liposomal bupivacaine is the first listed.
NCT04603911 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04603911 about?
NCT04603911 is a clinical study titled "RCT Comparing ESPB Solutions in Breast Surgery". The object of our research is to investigate the relative efficacy of liposomal bupivacaine administered via an Erector Spinae Plane (ESP) block as compared to our standard of care medication solution of (bupivacaine mixed with epinephrine, dexamethasone, and clonidine) for pain management in subjec...
What is the current status of trial NCT04603911?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 75 participants. The study started on 2020-12-04. Estimated completion is 2023-04-10.
What interventions are being tested in trial NCT04603911?
The interventions under investigation include: Liposomal bupivacaine (DRUG), Bupivacaine, epinephrine, dexamethasone, and clonidine (DRUG).
Who is sponsoring clinical trial NCT04603911?
This trial is sponsored by Tufts Medical Center, which has 169 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04603911's enrollment target sits among peer trials
75 900th of 2000 higher than 1,081 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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