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NCT03270514 · ClinicalTrials.gov registry record · Phase 3
Comparison of Sternal Wound Infiltration With Liposomal Bupivacaine v. Bupivacaine Hydrochloride
A Phase 3 study of Coronary Artery Disease and Valve Regurgitation, Mitral, sponsored by Kathirvel Subramaniam.
- Completed
- Registry status
- Phase 3
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT03270514: Completed Phase 3 study of Coronary Artery Disease and Valve Regurgitation, Mitral, sponsored by Kathirvel Subramaniam.
NCT03270514 is a Phase 3 study of Coronary Artery Disease and Valve Regurgitation, Mitral that has completed, run by Kathirvel Subramaniam. The registered enrollment target is 60 participants, below the 1,287-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03270514, a Phase 3 study of Coronary Artery Disease and Valve Regurgitation, Mitral, has completed, sponsored by Kathirvel Subramaniam.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
The aim of this study is to evaluate the analgesic efficacy and safety of wound infiltration with liposomal bupivacaine (LB) in patients undergoing cardiac surgery with sternotomy and cardiopulmonary bypass (CPB) and compare it with bupivacaine hydrochloride infiltration
Primary Outcome
Postoperative pain scores evaluated by numeric rating scale or (NRS) where 0- no pain and 10- worst pain, at rest and at movement
Conditions Studied
Interventions
- DRUG Bupivacaine Hydrochloride
- DRUG Exparel Injectable Product
Study Locations (1)
Pennsylvania
- UPMC Presbyterian Hospital - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2018-11-15 |
| Est. Completion | 2020-02-25 |
| Phase | Phase 3 |
What the finished NCT03270514 record still lists
NCT03270514 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 1,287-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (95% lower).
The record links to 4 conditions, with Coronary Artery Disease appearing as the primary indexed condition, and to 2 interventions - of which Bupivacaine Hydrochloride is the first listed.
NCT03270514 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT03270514 about?
NCT03270514 is a clinical study titled "Comparison of Sternal Wound Infiltration With Liposomal Bupivacaine v. Bupivacaine Hydrochloride". The aim of this study is to evaluate the analgesic efficacy and safety of wound infiltration with liposomal bupivacaine (LB) in patients undergoing cardiac surgery with sternotomy and cardiopulmonary bypass (CPB) and compare it with bupivacaine hydrochloride infiltration
What is the current status of trial NCT03270514?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 60 participants. The study started on 2018-11-15. Estimated completion is 2020-02-25.
What conditions does trial NCT03270514 study?
This clinical trial studies the following conditions: Coronary Artery Disease, Valve Regurgitation, Mitral, Coronary Artery Stenoses, Valve Regurgitation, Tricuspid.
What interventions are being tested in trial NCT03270514?
The interventions under investigation include: Bupivacaine Hydrochloride (DRUG), Exparel Injectable Product (DRUG).
Who is sponsoring clinical trial NCT03270514?
This trial is sponsored by Kathirvel Subramaniam, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03270514 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03270514's enrollment target sits among peer trials
60 169th of 219 higher than 47 of 219 other Coronary Artery Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Coronary Artery Disease 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.
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