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Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT04685421
Study type Interventional
Source Nicklaus Children's Hospital f/k/a Miami Children's Hospital
Contact
Status Terminated
Phase Phase 1
Start date July 15, 2021
Completion date June 1, 2023