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NCT06271265

Study to Evaluate the Pharmacokinetics and Safety of EXPAREL for Postoperative Analgesia in Subjects Undergoing Cardiac Surgery

A Multicenter, Open-label, Randomized, Bupivacaine-Controlled Study to Evaluate the Pharmacokinetics and Safety of EXPAREL for Postoperative Analgesia in Subjects Aged 0 to Less Than 6 Years Undergoing Cardiac Surgery
Pacira Pharmaceuticals, Inc·Phase 1·ClinicalTrials.gov·drugNot yet recruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Postoperative Pain
Drug/Device/Intervention
EXPAREL
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Pacira Pharmaceuticals, Inc
Timeline & enrollment
Phase
Phase 1
Start date
Feb 01, 2024
End date
Jul 01, 2025
Enrollment
48 participants
Primary outcome

The following model-predicted PK endpoint will be determined:,The following model-predicted PK endpoint will be determined:,The following model-predicted PK endpoint will be determined:,The following model-predicted PK endpoint will be determined:,The following model-predicted PK endpoint will be determined:,The following model-predicted PK endpoint will be determined:

Summary

This Phase 1, multicenter, open-label, randomized, bupivacaine-controlled study is designed
 to evaluate the pharmacokinetics (PK) and safety of EXPAREL vs. bupivacaine HCl for
 postsurgical analgesia in pediatric subjects aged 0 to less than 6 years of age undergoing
 cardiac surgery, utilizing local infiltration analgesia (LIA).

ICD-10 classifications
Acute painPostoperative intestinal obstructionPain, unspecifiedDuring surgical operationDuring surgical operation
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06271265
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06271265 through Pure Global AI's free database. This Phase 1 trial is sponsored by Pacira Pharmaceuticals, Inc and is currently Not yet recruiting. The study focuses on Postoperative Pain. Target enrollment is 48 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.