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

  • participants needed
  • sponsor
    Nicklaus Children's Hospital f/k/a Miami Children's Hospital
Updated on 3 June 2023


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. 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.

Condition Cardiac Conditions
Treatment Bupivacaine liposome
Clinical Study IdentifierNCT04685421
SponsorNicklaus Children's Hospital f/k/a Miami Children's Hospital
Last Modified on3 June 2023

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