Evaluating EXPAREL for pain relief after heart surgery in young children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: sarah.shaffer@pacira.com
• Phone: 973-451-4071

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• PECS II vs SPSIP nerve blocks for pain after mastectomy

  This study tests whether two ultrasound-guided nerve blocks (PECS II and SPSIP) differ in how much opioid patients need after mastectomy.

  Recruiting Bursa City Hospital · Nilufer, Bursa · NCT07929090

• Palatal Shield Technique to Reduce Pain and Improve Healing After Free Gingival Graft

  This randomized trial tests whether a collagen sponge with a protective palatal shield made of flowable resin helps reduce pain and improve healing after free gingival graft harvest.

  Recruiting Cairo University · Cairo, Cairo Governorate · NCT07926516

• Perfusion Index to Measure Postoperative Pain in Kids After Adenotonsillectomy

  This study tests whether the perfusion index can reliably reflect pain levels in children aged 1–12 after adenotonsillectomy, comparing standard care with an added glossopharyngeal nerve block.

  Recruiting Istanbul University · Istanbul, Istanbul · NCT07915804

• Anterior Knee Nerves Block vs Femoral Nerve Block for Knee Arthroscopy

  This trial tests whether an anterior nerves of the knee (ANK) block provides similar pain relief to a femoral nerve block after knee arthroscopy in adults, aiming to reduce quadriceps weakness.

  Recruiting Van Training and Research Hospital · Van · NCT07910500

• Natural Biopolymer-Based Irrigant for Root Canal Cleaning

  This trial tests a chitosan nanoparticle irrigant to improve cleaning and disinfection in single-rooted teeth with asymptomatic pulp necrosis undergoing endodontic treatment.

  Recruiting Minia University · Minya · NCT07901127

• Postoperative Pain Trajectories After Endometriosis Surgery

  This study tests how pain changes after endometriosis surgery and whether perioperative pain testing can predict who will have ongoing pain.

  Recruiting Centre Hospitalier Universitaire, Amiens · Amiens · NCT07882498

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.