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NCT04685421 · ClinicalTrials.gov registry record · Phase 1
Liposomal Bupivacaine Pharmacokinetic Study After Median Sternotomy Incision Infiltration in a Pediatric Cardiac Surgery
A Phase 1 study, sponsored by Nicklaus Children's Hospital f/k/a Miami Children's Hospital.
- Terminated
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
NCT04685421: Clinical Trial Phase 1 study, sponsored by Nicklaus Children's Hospital f/k/a Miami Children's Hospital.
NCT04685421 is a Phase 1 study that was terminated before completion, run by Nicklaus Children's Hospital f/k/a Miami Children's Hospital. The registered enrollment target is 15 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04685421, a Phase 1 study, was terminated before completion, sponsored by Nicklaus Children's Hospital f/k/a Miami Children's Hospital.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
Study Summary
The purpose of the study is to determine the plasma concentration of bupivacaine at various time points after Exparel (bupivacaine liposome injectable suspension, Pacira Pharmaceuticals, Inc., Parsippany, NJ) is injected subcutaneously for median sternotomy incisions in pediatric cardiac surgery patients.
Primary Outcome
To determine plasma bupivacaine levels after the use of Exparel 1.3% admixed with 0.25% bupivacaine and 0.9% Normal Saline in pediatric cardiac surgery patients ages two through seventeen years of age (Cohort I). Cohort II covers ages 2 \< 6.
Interventions
- DRUG Bupivacaine liposome
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2021-07-15 |
| Est. Completion | 2023-06-01 |
| Phase | Phase 1 |
Why NCT04685421 stopped before completion
NCT04685421 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 1 intervention - of which Bupivacaine liposome is the first listed.
NCT04685421 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04685421 about?
NCT04685421 is a clinical study titled "Liposomal Bupivacaine Pharmacokinetic Study After Median Sternotomy Incision Infiltration in a Pediatric Cardiac Surgery". The purpose of the study is to determine the plasma concentration of bupivacaine at various time points after Exparel (bupivacaine liposome injectable suspension, Pacira Pharmaceuticals, Inc., Parsippany, NJ) is injected subcutaneously for median sternotomy incisions in pediatric cardiac surgery pat...
What is the current status of trial NCT04685421?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2021-07-15. Estimated completion is 2023-06-01.
What interventions are being tested in trial NCT04685421?
The interventions under investigation include: Bupivacaine liposome (DRUG).
Who is sponsoring clinical trial NCT04685421?
This trial is sponsored by Nicklaus Children's Hospital f/k/a Miami Children's Hospital, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04685421's enrollment target sits among peer trials
15 1798th of 2000 higher than 157 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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