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NCT04333095 · ClinicalTrials.gov registry record · Phase 4
Sternal Block With Liposomal Bupivacaine vs. Saline Prior to Incision in Cardiac Surgery
A Phase 4 study, sponsored by Baylor Research Institute.
- Completed
- Registry status
- Phase 4
- Development phase
- 70
- Enrollment target
NCT04333095: Completed Phase 4 study, sponsored by Baylor Research Institute.
NCT04333095 is a Phase 4 study that has completed, run by Baylor Research Institute. The registered enrollment target is 70 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04333095, a Phase 4 study, has completed, sponsored by Baylor Research Institute.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 70 participants
- Enrollment target
Study Summary
The purpose of this study is to find out what effects (good and bad) that the study medicine called "liposomal bupivacaine" has on subjects that are undergoing a sternotomy. Liposomal bupivacaine solution, is a drug that the doctor will inject before they make the cut through patient's breastbone (sternotomy). Normally pain medicine like this is given right before the surgeon closes up the patient's breastbone, at the end of the surgery. For this study, they want to see if giving the medicine before they make the cut into the patient's breastbone helps their pain. They also want to find out if patients feel less pain after surgery with the study drug than they do with saline and possibly decrease the need for pain medicine. Subjects will be in the study for about 72 hours or until they are discharged from the hospital.
Primary Outcome
The amount of opioid medications used will be recorded during the routine postoperative course.
Interventions
- DRUG Liposomal bupivacaine
- DRUG Normal Saline Flush, 0.9% Injectable Solution_#1
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2020-02-06 |
| Est. Completion | 2021-06-26 |
| Phase | Phase 4 |
What the finished NCT04333095 record still lists
NCT04333095 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 2 interventions - of which Liposomal bupivacaine is the first listed.
NCT04333095 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04333095 about?
NCT04333095 is a clinical study titled "Sternal Block With Liposomal Bupivacaine vs. Saline Prior to Incision in Cardiac Surgery". The purpose of this study is to find out what effects (good and bad) that the study medicine called "liposomal bupivacaine" has on subjects that are undergoing a sternotomy. Liposomal bupivacaine solution, is a drug that the doctor will inject before they make the cut through patient's breastbone (s...
What is the current status of trial NCT04333095?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 70 participants. The study started on 2020-02-06. Estimated completion is 2021-06-26.
What interventions are being tested in trial NCT04333095?
The interventions under investigation include: Liposomal bupivacaine (DRUG), Normal Saline Flush, 0.9% Injectable Solution_#1 (DRUG).
Who is sponsoring clinical trial NCT04333095?
This trial is sponsored by Baylor Research Institute, which has 180 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04333095's enrollment target sits among peer trials
70 1043rd of 2000 higher than 931 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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