Actively Recruiting
Study to Evaluate the Pharmacokinetics and Safety of EXPAREL for Postoperative Analgesia in Subjects Undergoing Cardiac Surgery
Led by Pacira Pharmaceuticals, Inc · Updated on 2025-12-29
48
Participants Needed
5
Research Sites
144 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Study to Evaluate the Pharmacokinetics and Safety of EXPAREL for Postoperative Analgesia in Subjects Undergoing Cardiac Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 or guardian can speak, read, and understand the language of the informed consent form and provide consent
- Parent or guardian can follow the study visit schedule and complete all assessments for the participant
You will not qualify if you...
- History of hypersensitivity or reactions to EXPAREL, bupivacaine HCl, other amide-type local anesthetics, or opioid medications
- Received EXPAREL or bupivacaine HCl within 30 days before study drug administration
- Received another investigational product within 30 days or 5 elimination half-lives before study drug administration, or planned to receive one during the study
- History of preterm birth before 35 weeks of pregnancy
- History of bleeding disorders or immune deficiencies
- Any disease or condition that increases vulnerability to investigational products or procedures, as judged by the investigator
- Recent or potential exposure to COVID-19
- Cardiac surgery canceled and cannot be rescheduled within 30 days of consent
- Need for delayed wound closure
- Withdrawal of informed consent before randomization
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Indiana University Health, Riley Hospital For Children
Indianapolis, Indiana, United States, 46202
Actively Recruiting
2
St. Louis Children's Hospital (SLCH)
St Louis, Missouri, United States, 63110
Actively Recruiting
3
Duke University Health System
Durham, North Carolina, United States, 27710
Actively Recruiting
4
University of Oklahoma (OU) - Medical Center - The Children's Hospital
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
5
The University of Texas Health Science Center at Houston (UTHSC-H) - McGovern Medical School
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
S
Sarah Shaffer
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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