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
Study on Pain Relief Methods After Heart Surgery in Young Children
Brandon Tanner
Primary Investigator
Brief description of study
Detailed description of study
Subject enrollment for Part 2 will commence upon complete enrollment of Part 1, establishment of an appropriate study drug dose from the PK, and safety analysis of Part 1 and Data Safety Monitoring Board (DSMB) recommendations to proceed to Part 2. Part 2 will enroll approximately 16 subjects, aged 6 months to less than 2 years to obtain information on PK and safety. Subjects will be randomized 1:1 (8 EXPAREL subjects and 8 bupivacaine HCl subjects) to receive either a single dose of EXPAREL or 0.25% bupivacaine HCl using LIA. The overall PK and safety profiles from Part 2 will be completed, analyzed, and reviewed to establish an appropriate study drug dose for Part 3.
Subject enrollment for Part 3 will commence upon complete enrollment of Part 2, establishment of an appropriate study drug dose from the PK and safety analysis of Part 2, and DSMB recommendations to proceed to Part 3.
Part 3 will enroll approximately 16 subjects aged 0 to less than 6 months to obtain information on PK and safety. Subjects will be randomized 1:1 (8 EXPAREL subjects and 8 bupivacaine HCL subjects) to receive either a single dose of EXPAREL or 0.25% bupivacaine HCl using LIA.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Postoperative Pain, Riley
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Age: 6 years or below
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Gender: All
Inclusion Criteria:
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.
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
This study investigates the effectiveness and safety of different pain relief methods after heart surgery in young children. The purpose is to compare two types of pain relief: an investigational medication and bupivacaine HCl, which are used to reduce pain after surgery. The study involves children aged 0 to less than 6 years who have heart conditions and are undergoing surgery. It is conducted in multiple parts, each focusing on different age groups to understand how the medications work in each group.
In this study, children will receive either the investigational medication or bupivacaine HCl through a method called local infiltration analgesia, which means the medicine is injected directly into the area around the surgery site to manage pain. The study will monitor how the body processes the medication and its safety in young children. Participation involves routine checks and assessments by the study team to ensure safety and gather information on how well the medications work.
- Who can participate: Children aged 0 to less than 6 years with congenital heart defects scheduled for heart surgery are eligible. Participants must be classified as ASA Classes 1 to 4 and have a parent or guardian able to provide consent and follow the study schedule.
- Study details: Participants will receive either an investigational medication or bupivacaine HCl to manage pain after surgery. The investigational medication is given through local infiltration analgesia.