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 range0 Years – 6 Years
SexALL
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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
✕. 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
✕
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: