Study to Evaluate the Pharmacokinetics and Safety of EXPAREL for Postoperative Analgesia in Subje… (NCT06271265) | Clinical Trial Compass
RecruitingPhase 1
Study to Evaluate the Pharmacokinetics and Safety of EXPAREL for Postoperative Analgesia in Subjects Undergoing Cardiac Surgery
United States48 participantsStarted 2024-03-29
Plain-language summary
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
Age range
0 Years – 6 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The following model-predicted PK endpoint will be determined:
Timeframe: through 72 hours
2
The following model-predicted PK endpoint will be determined:
Timeframe: through 72 hours
3
The following model-predicted PK endpoint will be determined:
Timeframe: through 72 hours
4
The following model-predicted PK endpoint will be determined:
Timeframe: through 72 hours
5
The following model-predicted PK endpoint will be determined:
Timeframe: through 72 hours
6
The following model-predicted PK endpoint will be determined:
. 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.