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

Inclusion Criteria

All of the following inclusion criteria must be met for eligibility:

• Pediatric participants with congenital heart defects planned to undergo cardiac surgery with cardiopulmonary bypass
• 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
• American Society of Anesthesiologists (ASA) Classes 1 through 4.
• Parent/guardian is able to speak, read, and understand the language of the ICF and provide informed consent for the participant.
• 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:

• History of hypersensitivity or idiosyncratic reactions or contradictions to EXPAREL, bupivacaine HCl, or other amide-type local anesthetics or to opioid medications
• Administration of EXPAREL or bupivacaine HCl within 30 days prior to IP administration
• Administration of an IP within 30 days or 5 elimination half-lives of such IP, whichever is longer, prior to IP administration, or planned administration of another IP or procedure during participation in this study
• History of preterm birth (before 35 weeks of pregnancy)
• History of coagulopathies or immunodeficiency disorders
• Disease or condition that, in the opinion of the Investigator, indicates an increased vulnerability to IPs and/or procedures
• Recent or potential exposure to COVID-19
• Cardiac surgery has been canceled and cannot be rescheduled within 30 days of signing the ICF because of any reason.
• Necessity in delayed wound closure
• Informed consent withdrawn before randomization