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

Recruiting now · Phase 1

Conditions studied: Postoperative Pain

In brief

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).

Key facts

Study ID

NCT06271265

Run by

Pacira Pharmaceuticals, Inc

People needed

48

Starts

2024-03-29

Expected to finish

2027-01-01

Last updated by the study team

2025-12-29

Who can join

Age: any, up to 6. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Indiana University Health, Riley Hospital For Children — Indianapolis, Indiana, United States (enrolling)
• St. Louis Children's Hospital (SLCH) — St Louis, Missouri, United States (enrolling)
• Duke University Health System — Durham, North Carolina, United States (enrolling)
• University of Oklahoma (OU) - Medical Center - The Children's Hospital — Oklahoma City, Oklahoma, United States (enrolling)
• The University of Texas Health Science Center at Houston (UTHSC-H) - McGovern Medical School — Houston, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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