Study to Evaluate the Pharmacokinetics and Safety of EXPAREL for Postoperative Analgesia in Subjects Undergoing Cardiac Surgery
Condition(s) studied
Investigational drug(s) / intervention(s)
EXPAREL: A single dose of EXPAREL Injectable Product via LIA
bupivacaine: A single dose of 0.25% bupivacaine via LIA
Study 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).
Eligibility
Primary outcome measure(s)
- The following model-predicted PK endpoint will be determined: — through 72 hours
• Area under the plasma concentration-versus-time curve (AUClast and AUC0-inf) - The following model-predicted PK endpoint will be determined: — through 72 hours
• Maximum observed plasma concentration (Cmax) - The following model-predicted PK endpoint will be determined: — through 72 hours
• Time of maximum observed plasma concentration (Tmax) - The following model-predicted PK endpoint will be determined: — through 72 hours
• The apparent terminal elimination half-life (t1/2) - The following model-predicted PK endpoint will be determined: — through 72 hours
• Apparent clearance (CL) - The following model-predicted PK endpoint will be determined: — through 72 hours
• Apparent volume of distribution (Vd)
Trial sites (5)
| Facility | City | Region | Status |
|---|---|---|---|
| Indiana University Health, Riley Hospital For Children | Indianapolis | Indiana | Recruiting |
| St. Louis Children's Hospital (SLCH) | St Louis | Missouri | Recruiting |
| Duke University Health System | Durham | North Carolina | Recruiting |
| University of Oklahoma (OU) - Medical Center - The Children's Hospital | Oklahoma City | Oklahoma | Recruiting |
| The University of Texas Health Science Center at Houston (UTHSC-H) - McGovern Medical School | Houston | Texas | Recruiting |
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06271265 on ClinicalTrials.gov ↗ ← All trials in the USA