NCT06271265 · Pacira Pharmaceuticals, Inc
Study to Evaluate the Pharmacokinetics and Safety of EXPAREL for Postoperative Analgesia in Subjects Undergoing Cardiac Surgery
What this study is about
This Phase 1, conducted at multiple hospitals, where both patients and doctors know the treatment given, randomly assigned, bupivacaine-controlled study is designed to evaluate the how the drug moves through the body (PK) and safety of EXPAREL vs.
View original scientific description
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 participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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
Where
- Indianapolis, Indiana
- St Louis, Missouri
- Durham, North Carolina
- Oklahoma City, Oklahoma
- Houston, Texas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 29, 2025 · Source of record for eligibility and locations