Liposomal Bupivacaine Pharmacokinetic Study After Median Sternotomy Incision Infiltration in a Pediatric Cardiac Surgery

Stopped early · Phase 1

Conditions studied: Cardiac Conditions

In brief

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.

Key facts

Study ID

NCT04685421

Run by

Nicklaus Children's Hospital f/k/a Miami Children's Hospital

People needed

15

Starts

2021-07-15

Expected to finish

2023-06-01

Last updated by the study team

2023-06-05

Who can join

Age: 2 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Every elective pediatric surgery patient ages two through seventeen years old, inclusive.

You may not qualify if…

• Patients who fall outside of the age range for the study will be excluded. -Patients known to have had an anaphylactic or severe reaction to the drug or its components will not be enrolled. Any with Significant Liver Disease will also be excluded. Emergency patients will be excluded. Pregnant patients will be excluded.

Where it is running

• Nickalus Children's Hospital f/k/a Miami Children's Hospital — Miami, Florida, United States

Full record on ClinicalTrials.gov

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