Overview

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

Status:
Recruiting

Trial end date:
2023-01-06

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 1

Accepts Healthy Volunteers?

Details

Lead Sponsor:

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

Treatments:

Bupivacaine

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

- 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.