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Recruiting Phase 1

Study to Evaluate the Pharmacokinetics and Safety of EXPAREL for Postoperative Analgesia in Subjects Undergoing Cardiac Surgery

NCT06271265 · tracked via the Priya Life Science USA tracker
Phase
Phase 1
Started
2024-03-29
Last updated
2025-12-29

Condition(s) studied

Postoperative Pain

Investigational drug(s) / intervention(s)

EXPAREL →bupivacaine →

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

Sex
ALL
Min age
0 Years
Max age
6 Years
Healthy volunteers
No
Inclusion Criteria: All of the following inclusion criteria must be met for eligibility: 1. Pediatric participants with congenital heart defects planned to undergo cardiac surgery with cardiopulmonary bypass 2. 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 3. American Society of Anesthesiologists (ASA) Classes 1 through 4. 4. Parent/guardian is able to speak, read, and understand the language of the ICF and provide informed consent for the participant. 5. Parent/guardian is able to adhere to the study visit schedule and complete all study assessments for the participant. Exclusion Criteria: Exclusion Criteria: A participant will not be eligible for the study if any of the following exclusion criteria are met: 1. History of hypersensitivity or idiosyncratic reactions or contradictions to EXPAREL, bupivacaine HCl, or other amide-type local anesthetics or to opioid medications 2. Administration of EXPAREL or bupivacaine HCl within 30 days prior to IP administration 3. 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 4. History of preterm birth (before 35 weeks of pregnancy) 5. History of coagulopathies or immunodeficiency disorders 6. Disease or condition that, in the opinion of the Investigator, indicates an increased vulnerability to IPs and/or procedures 7. Recent or potential exposure to COVID-19 8. Cardiac surgery has been canceled and cannot be rescheduled within 30 days of signing the ICF because of any reason. 9. Necessity in delayed wound closure 10. Informed consent withdrawn before randomization

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)

FacilityCityRegionStatus
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
Official registry record

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