Evaluating EXPAREL for pain relief after heart surgery in young children

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

This study is testing if a new pain relief medicine called EXPAREL works better and is safer than a standard painkiller for young children after heart surgery.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Ages: 0 Years to 6 Years
• Sex: All
• Sponsor: Pacira Pharmaceuticals, Inc (Industry-sponsored)
• Locations: 5 sites (Indianapolis, Indiana and 4 other locations)
• Trial ID: NCT06271265 on ClinicalTrials.gov

What this trial studies

This Phase 1, multicenter, open-label study aims to assess the pharmacokinetics and safety of EXPAREL compared to bupivacaine HCl for postoperative analgesia in pediatric patients undergoing cardiac surgery. The study is divided into three parts, enrolling approximately 48 subjects aged 0 to less than 6 years. In each part, subjects will receive either EXPAREL or bupivacaine HCl through local infiltration analgesia, with the first part focusing on children aged 2 to less than 6 years, the second on those aged 6 months to less than 2 years, and the third on infants aged 0 to less than 6 months. The results will help establish appropriate dosing and safety profiles for the medications used.

Who should consider this trial

Good fit: Ideal candidates for this study are pediatric patients aged 0 to less than 6 years who are scheduled for cardiac surgery.

Not a fit: Patients with a history of hypersensitivity to bupivacaine or other amide-type local anesthetics may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a safer and more effective pain management option for young children undergoing cardiac surgery.

How similar studies have performed: Other studies have shown promise in using local anesthetics for postoperative pain management, but this specific approach with EXPAREL in pediatric cardiac surgery is novel.

Eligibility criteria

Inclusion Criteria:

All of the following inclusion criteria must be met for eligibility:

1. Pediatric participants with congenital heart defects planned to undergo cardiac surgery with cardiopulmonary bypass
2. 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
3. American Society of Anesthesiologists (ASA) Classes 1 through 4.
4. Parent/guardian is able to speak, read, and understand the language of the ICF and provide informed consent for the participant.
5. Parent/guardian is able to adhere to the study visit schedule and complete all study assessments for the participant.

Exclusion Criteria:

Exclusion Criteria:

A participant will not be eligible for the study if any of the following exclusion criteria are met:

1. History of hypersensitivity or idiosyncratic reactions or contradictions to EXPAREL, bupivacaine HCl, or other amide-type local anesthetics or to opioid medications
2. Administration of EXPAREL or bupivacaine HCl within 30 days prior to IP administration
3. 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
4. History of preterm birth (before 35 weeks of pregnancy)
5. History of coagulopathies or immunodeficiency disorders
6. Disease or condition that, in the opinion of the Investigator, indicates an increased vulnerability to IPs and/or procedures
7. Recent or potential exposure to COVID-19
8. Cardiac surgery has been canceled and cannot be rescheduled within 30 days of signing the ICF because of any reason.
9. Necessity in delayed wound closure
10. Informed consent withdrawn before randomization

Where this trial is running

Indianapolis, Indiana and 4 other locations

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

Study contacts

• Study coordinator: Sarah Shaffer

Conditions Postoperative Pain; Analgesia; Cardiac Surgery; Pediatric