Study to Evaluate the Pharmacokinetics and Safety of EXPAREL for Postoperative Analgesia in Subjects Undergoing Cardiac Surgery
NCT06271265
This study is recruiting at 5 US sites in 5 states, according to its ClinicalTrials.gov record last updated .
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).
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- Postoperative Pain
Eligibility basics and study details
- Study type
- Interventional
- Phase
- Phase 1
- Ages
- 0 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Sponsor
- Pacira Pharmaceuticals, Inc
- Last updated on ClinicalTrials.gov
- December 29, 2025
These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.
US recruiting sites
Indiana · 1
- Indiana University Health, Riley Hospital For Children · Indianapolis, IN
Missouri · 1
- St. Louis Children's Hospital (SLCH) · St Louis, MO
North Carolina · 1
- Duke University Health System · Durham, NC
Oklahoma · 1
- University of Oklahoma (OU) - Medical Center - The Children's Hospital · Oklahoma City, OK
Texas · 1
- The University of Texas Health Science Center at Houston (UTHSC-H) - McGovern Medical School · Houston, TX
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.