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

Phase 1

Terminated

• Conditions: Cardiac Conditions
• Interventions: Drug: Bupivacaine liposome

• Registration Number: NCT04685421
• Lead Sponsor: Nicklaus Children's Hospital f/k/a Miami Children's Hospital

Brief 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.

Detailed Description

To determine the pharmacokinetic profile and peak bupivacaine plasma concentration with the use of an Exparel/bupivacaine mixture in children ages two through seventeen (Cohort I). Cohort II covers ages 2 \<6. We will be collecting blood samples at different times during 96 hours or until the patient is discharged from the hospital. There will be two different groups participating in the study alternating the times in which the blood samples will be collected. We hypothesize that peak plasma concentration will be significantly less than the toxic plasma concentration.

Study Timeline

• Study First Submitted: 2020-12-22
• Study First Submitted QC: 2020-12-22
• Study First Posted: 2020-12-28
• Study Start: 2021-07-15
• Status Verified: 2023-06
• Primary Completion: 2023-06-01
• Study Completion: 2023-06-01
• Last Update Submitted: 2023-06-01
• Last Update Posted: 2023-06-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Liposomal Bupivacaine PK	Bupivacaine liposome	Liposomal Bupivacaine PKs collections up to 96 hours on children from 2 to 17 years in pediatric cardiac surgeries.

Primary Outcome Measures

Name	Time	Method
Bupivacaine-Exparel levels	96 hours	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.

Trial Locations

Locations (1)

Nickalus Children's Hospital f/k/a Miami Children's Hospital; 🇺🇸 Miami, Florida, United States