Study to Evaluate the Pharmacokinetics and Safety of EXPAREL for Postoperative Analgesia in Subjects Undergoing Cardiac Surgery
NCT ID: NCT06271265
Last Updated: 2025-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
48 participants
INTERVENTIONAL
2024-03-29
2027-01-31
Brief Summary
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Detailed Description
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Part 1 will enroll approximately 16 subjects, aged 2 to less than 6 years to obtain information on PK and safety. Subjects will be randomized 1:1 (8 EXPAREL subjects and 8 bupivacaine HCl subjects) to receive either a single dose of EXPAREL 4 mg/kg (not to exceed a maximum total dose of 266 mg) or 0.25% bupivacaine HCl 2 mg/kg (not to exceed a maximum total dose of 175 mg) using LIA. The overall PK and safety profiles from Part 1 will be completed, analyzed, and reviewed to establish an appropriate study drug dose for Part 2.
Subject enrollment for Part 2 will commence upon complete enrollment of Part 1, establishment of an appropriate study drug dose from the PK, and safety analysis of Part 1 and Data Safety Monitoring Board (DSMB) recommendations to proceed to Part 2. Part 2 will enroll approximately 16 subjects, aged 6 months to less than 2 years to obtain information on PK and safety. Subjects will be randomized 1:1 (8 EXPAREL subjects and 8 bupivacaine HCl subjects) to receive either a single dose of EXPAREL or 0.25% bupivacaine HCl using LIA. The overall PK and safety profiles from Part 2 will be completed, analyzed, and reviewed to establish an appropriate study drug dose for Part 3.
Subject enrollment for Part 3 will commence upon complete enrollment of Part 2, establishment of an appropriate study drug dose from the PK and safety analysis of Part 2, and DSMB recommendations to proceed to Part 3.
Part 3 will enroll approximately 16 subjects aged 0 to less than 6 months to obtain information on PK and safety. Subjects will be randomized 1:1 (8 EXPAREL subjects and 8 bupivacaine HCL subjects) to receive either a single dose of EXPAREL or 0.25% bupivacaine HCl using LIA.
Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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EXPAREL
A total of approximately 24 subjects (8 subjects per Part) will be enrolled. Subjects in this arm will receive EXPAREL
EXPAREL
A single dose of EXPAREL Injectable Product via LIA
bupivacaine
A total of approximately 24 subjects (8 subjects per Part) will be enrolled. Subjects in this arm will receive bupivacaine
bupivacaine
A single dose of 0.25% bupivacaine via LIA
Interventions
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bupivacaine
A single dose of 0.25% bupivacaine via LIA
EXPAREL
A single dose of EXPAREL Injectable Product via LIA
Eligibility Criteria
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Inclusion Criteria
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
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
0 Years
6 Years
ALL
No
Sponsors
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Pacira Pharmaceuticals, Inc
INDUSTRY
Responsible Party
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Locations
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St. Louis Children's Hospital (SLCH)
St Louis, Missouri, United States
Duke University Health System
Durham, North Carolina, United States
University of Oklahoma (OU) - Medical Center - The Children's Hospital
Oklahoma City, Oklahoma, United States
The University of Texas Health Science Center at Houston (UTHSC-H) - McGovern Medical School
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Kyle Stumbaugh
Role: primary
Amy Patrylick
Role: primary
Amir L Butt, MD, MPH
Role: primary
Emad Sorial
Role: primary
Other Identifiers
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402-C-125
Identifier Type: -
Identifier Source: org_study_id