Study to Evaluate the Pharmacokinetics and Safety of EXPAREL for Postoperative Analgesia in Subjects Undergoing Cardiac Surgery
Trial Parameters
Brief 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).
Eligibility Criteria
Inclusion Criteria: All of the following inclusion criteria must be met for eligibility: 1. Pediatric participants with congenital heart defects planned to undergo cardiac surgery with cardiopulmonary bypass 2. Male or female participants from 0 to less than 6 years of age on the day of surgery: 2 years to less than 6 years of age for Part 1; 6 months to less than 2 years of age for Part 2; 0 to less than 6 months of age for Part 3 3. American Society of Anesthesiologists (ASA) Classes 1 through 4. 4. Parent/guardian is able to speak, read, and understand the language of the ICF and provide informed consent for the participant. 5. Parent/guardian is able to adhere to the study visit schedule and complete all study assessments for the participant. Exclusion Criteria: Exclusion Criteria: A participant will not be eligible for the study if any of the following exclusion criteria are met: 1. History of hypersensitivity or idiosyncratic reactions or contradictions to EXPAREL, bupivacaine HC