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

Sponsor
Nicklaus Children's Hospital f/k/a Miami Children's Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04685421
Collaborator
(none)
30
Enrollment
1
Location
1
Arm
19.5
Anticipated Duration (Months)
1.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Bupivacaine liposome
 Phase 1

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. 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 Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Study population of 30 pediatric cardiac surgery patients undergoing elective operations between the ages of two through seventeen years.Study population of 30 pediatric cardiac surgery patients undergoing elective operations between the ages of two through seventeen years.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Liposomal Bupivacaine Pharmacokinetic Study After Median Sternotomy Incision Infiltration in a Pediatric Cardiac Surgery
Actual Study Start Date :
Jul 15, 2021
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Mar 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Liposomal Bupivacaine PK

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

Drug: Bupivacaine liposome
Liposomal Bupivacaine PKs collections up to 96 hours on children from 2 to 17 years in pediatric cardiac surgeries.
Other Names:
  • Bupivacaine liposome PKs

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Years to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Nickalus Children's Hospital f/k/a Miami Children's Hospital Miami Florida United States 33155

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Christopher F Tirotta, MD, Nicklaus Children's Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Christopher Tirotta, MD, MBA, Chief of Anesthesiology Department, Nicklaus Children's Hospital f/k/a Miami Children's Hospital
    ClinicalTrials.gov Identifier:
    NCT04685421
    Other Study ID Numbers:
    • 2020005RI
    First Posted:
    Dec 28, 2020
    Last Update Posted:
    Apr 6, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Christopher Tirotta, MD, MBA, Chief of Anesthesiology Department, Nicklaus Children's Hospital f/k/a Miami Children's Hospital
    pediatric cardiac surgery
    median sternotomy incision
    Additional relevant MeSH terms:
    Surgical Wound
    Bupivacaine

    Study Results

    No Results Posted as of Apr 6, 2022