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

Phase 1TerminatedNCT04685421

Nicklaus Children's Hospital f/k/a Miami Children's Hospital15 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cardiac Conditions

Interventions

Bupivacaine liposomeDRUG

Liposomal Bupivacaine PKs collections up to 96 hours on children from 2 to 17 years in pediatric cardiac surgeries.

Eligibility

Sex: ALLMin age: 2 YearsMax age: 17 Years

Medical Language ↔ Plain English

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.

Locations (1)

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

Miami, Florida, United States

Outcomes

Primary Outcomes

Bupivacaine-Exparel levels

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.

Time frame: 96 hours

Data from ClinicalTrials.gov

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