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

Eligibility Criteria

• 1. Parent/guardian able to speak, read, and understand the language of the ICF and provide informed consent for the subject.
• 2. American Society of Anesthesiologists (ASA) Class 1-3.
• 3. Male or female subjects from 0 to less than 6 years of age on the day of surgery. For Part 1, the subject's age should be 2 years to less than 6 years. For Part 2, the subject's age should be 6 months to less than 2 years. For Part 3, the subject's age should be 0 to less than 6 months.
• 4. Parent/guardian able to adhere to the study visit schedule and complete all study assessments for the subject.
• 1. History of hypersensitivity or idiosyncratic reactions or contradictions to bupivacaine HCl or other amide-type local anesthetics or to opioid medications.
• 2. Administration of EXPAREL or bupivacaine HCl within 30 days prior to study drug administration.
• 3. History of coagulopathies or immunodeficiency disorders.
• 4. Clinically significant medical or psychiatric disease that, in the opinion of the investigator, indicates an increased vulnerability to study drugs and/or procedures.
• 5. History of pre-term birth (babies born before 37 weeks of pregnancy).
• 6. Administration of an investigational drug within 30 days or 5 elimination half-lives of such investigational drug, whichever is longer, prior to study drug administration, or planned administration of another investigational product or procedure during the subject's participation in this study.
• 7. Concern about a subject's recent or potential exposure to COVID-19, or if the subject is not medically fit/cleared for surgery due to suspected COVID-19 illness/symptoms (or other serious illness).