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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 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.

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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.

Interventions

  • DRUG Bupivacaine liposome

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2021-07-15
Est. Completion 2023-06-01
Phase Phase 1

What the Registry Record Tells You About NCT04685421

The ClinicalTrials.gov registry entry for NCT04685421 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nicklaus Children's Hospital f/k/a Miami Children's Hospital, which has 9 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Bupivacaine liposome is the first listed.

NCT04685421 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.