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

NCT06271265 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: 402-C-125
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 5

Brief 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).

Conditions

Postoperative Pain

Keywords

Analgesia; Cardiac Surgery; Pediatric

Outcome Measures

Primary Outcomes (6)

• The following model-predicted PK endpoint will be determined:

  • Area under the plasma concentration-versus-time curve (AUClast and AUC0-inf)

  through 72 hours

• The following model-predicted PK endpoint will be determined:

  • Maximum observed plasma concentration (Cmax)

  through 72 hours

• The following model-predicted PK endpoint will be determined:

  • Time of maximum observed plasma concentration (Tmax)

  through 72 hours

• The following model-predicted PK endpoint will be determined:

  • The apparent terminal elimination half-life (t1/2)

  through 72 hours

• The following model-predicted PK endpoint will be determined:

  • Apparent clearance (CL)

  through 72 hours

• The following model-predicted PK endpoint will be determined:

  • Apparent volume of distribution (Vd)

  through 72 hours

Secondary Outcomes (8)

• Vitals change from Baseline:

  up to 4 postoperative days

• Vitals change from Baseline:

  up to 4 postoperative days

• Vitals change from Baseline:

  up to 4 postoperative days

• Vitals change from Baseline:

  up to 4 postoperative days

• Vitals change from Baseline:

  up to 4 postoperative days

Study Arms (2)

EXPAREL

EXPERIMENTAL

A total of approximately 24 subjects (8 subjects per Part) will be enrolled. Subjects in this arm will receive EXPAREL

Drug: EXPAREL

bupivacaine

ACTIVE COMPARATOR

A total of approximately 24 subjects (8 subjects per Part) will be enrolled. Subjects in this arm will receive bupivacaine

Drug: bupivacaine

Interventions

EXPAREL DRUG

A single dose of EXPAREL Injectable Product via LIA

EXPAREL

bupivacaine DRUG

A single dose of 0.25% bupivacaine via LIA

bupivacaine

Eligibility Criteria

• Age: 0 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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/guardian is able to speak, read, and understand the language of the ICF and provide informed consent for the participant.
• Parent/guardian is able to adhere to the study visit schedule and complete all study assessments for the participant.

You may not qualify if:

• History of hypersensitivity or idiosyncratic reactions or contradictions to EXPAREL, bupivacaine HCl, or other amide-type local anesthetics or to opioid medications
• Administration of EXPAREL or bupivacaine HCl within 30 days prior to IP administration
• 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
• History of preterm birth (before 35 weeks of pregnancy)
• History of coagulopathies or immunodeficiency disorders
• Disease or condition that, in the opinion of the Investigator, indicates an increased vulnerability to IPs and/or procedures
• Recent or potential exposure to COVID-19
• Cardiac surgery has been canceled and cannot be rescheduled within 30 days of signing the ICF because of any reason.
• Necessity in delayed wound closure
• Informed consent withdrawn before randomization

Sponsors & Collaborators

• Pacira Pharmaceuticals, Inc: lead

Study Sites (5)

Indiana University Health, Riley Hospital For Children

Indianapolis, Indiana, 46202, United States

RECRUITING

St. Louis Children's Hospital (SLCH)

St Louis, Missouri, 63110, United States

RECRUITING

Duke University Health System

Durham, North Carolina, 27710, United States

RECRUITING

University of Oklahoma (OU) - Medical Center - The Children's Hospital

Oklahoma City, Oklahoma, 73104, United States

RECRUITING

The University of Texas Health Science Center at Houston (UTHSC-H) - McGovern Medical School

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

Sarah Shaffer

CONTACT

973-451-4071; sarah.shaffer@pacira.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2024
• First Posted: February 21, 2024
• Study Start: March 29, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: December 29, 2025

Record last verified: 2025-11

Locations

US (5)