Viewing Study NCT04685421



Ignite Creation Date: 2024-05-06 @ 3:35 PM
Last Modification Date: 2024-10-26 @ 1:52 PM
Study NCT ID: NCT04685421
Status: TERMINATED
Last Update Posted: 2023-06-05
First Post: 2020-12-22

Brief Title: Liposomal Bupivacaine Pharmacokinetic Study After Median Sternotomy Incision Infiltration in a Pediatric Cardiac Surgery
Sponsor: Nicklaus Childrens Hospital fka Miami Childrens Hospital
Organization: Nicklaus Childrens Hospital fka Miami Childrens Hospital

Study Overview

Official Title: Liposomal Bupivacaine Pharmacokinetic Study After Median Sternotomy Incision Infiltration in a Pediatric Cardiac Surgery
Status: TERMINATED
Status Verified Date: 2023-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: PI Christopher Tirotta no longer at NCH as of 5-26-23
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: CohortI-II
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
Detailed Description: To determine the pharmacokinetic profile and peak bupivacaine plasma concentration with the use of an Exparelbupivacaine 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: True
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None