Study to Evaluate the Pharmacokinetics and Safety of EXPAREL for Postoperative Analgesia in Subjects Undergoing Cardiac Surgery (NCT06271265)
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
🩺 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: Review the eligibility criteria below.
Location: Indiana University Health, Riley Hospital For Children — Indianapolis, Indiana
Age range: 0 Years to 6 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 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
📞 Contact the Study Coordinator
Phone: (973) 451-4071
Email: sarah.shaffer@pacira.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 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.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.