Clinical Trial

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

Recruiting Phase 1
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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).
Protocol Amendment History 8 amendments
This ClinicalTrials.gov record has been amended 8 times since 2024-02-14; most recent amendment 2025-12-19.
Status change: Not Yet Recruiting → Recruiting 2024-05-09
Trial Details
NCT Number NCT06271265
Lead Sponsor Pacira Pharmaceuticals, Inc
Conditions Postoperative Pain
Enrollment 48 participants
Start Date 2024-03-29
Primary Completion 2027-01 (estimated)
Study Completion 2027-01 (estimated)
Updated on ClinicalTrials.gov 2025-12-29