RecruitingPhase 1NCT06271265

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

Sponsor

Pacira Pharmaceuticals, Inc

Enrollment

48 participants

Start Date

Mar 29, 2024

Study Type

INTERVENTIONAL

Conditions

Postoperative Pain

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

Min Age: 0 YearsMax Age: 6 Years

Inclusion Criteria5

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 Criteria10

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