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).
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.
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)
Single group
EXPAREL
DrugA single dose of EXPAREL Injectable Product via LIA
bupivacaine
DrugA single dose of 0.25% bupivacaine via LIA
The following model-predicted PK endpoint will be determined:
• Area under the plasma concentration-versus-time curve (AUClast and AUC0-inf)
The following model-predicted PK endpoint will be determined:
• Maximum observed plasma concentration (Cmax)
The following model-predicted PK endpoint will be determined:
• Time of maximum observed plasma concentration (Tmax)
The following model-predicted PK endpoint will be determined:
• The apparent terminal elimination half-life (t1/2)
Vitals change from Baseline:
temperature
Vitals change from Baseline:
heart rate
Vitals change from Baseline:
respiratory rate
Vitals change from Baseline:
oxygen saturation
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