Who is eligible for clinical trial NCT06271265?

Participants must meet protocol criteria for Postoperative Pain. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT06271265 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2025-12-19

Study to Evaluate the Pharmacokinetics and Safety of EXPAREL for Postoperative Analgesia in Subjects Undergoing Cardiac Surgery (NCT06271265)

🟢 Recruiting Phase1 💊 Investigational Drug / Biologic Sponsor: Pacira Pharmaceuticals, Inc

🩺 Plain-English Summary (8th-Grade Level)

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).

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (6 items) and avoid the listed exclusions (11 items).

Location: Indiana University Health, Riley Hospital For Children — Indianapolis, Indiana

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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.

Usually NOT eligible if any of the following apply:

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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (5 Sites)

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

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗