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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-15

Study Completion Date

2023-06-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cardiac Conditions

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Study population of 30 pediatric cardiac surgery patients (ages 2 to 17\_cohort I) undergoing elective operations between the ages of two through seventeen years. Cohort II (Ages 2 \< 6)

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Liposomal Bupivacaine PK

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

Group Type EXPERIMENTAL

Bupivacaine liposome

Intervention Type DRUG

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

Interventions

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Bupivacaine liposome

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

Intervention Type DRUG

Other Intervention Names

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Bupivacaine liposome PKs

Eligibility Criteria

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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.

Minimum Eligible Age

2 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No