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

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Pacira Pharmaceuticals, Inc
Study ID
NCT06271265
Phase
PHASE1
Status
Recruiting
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Conditions

  • Postoperative Pain

Eligibility Criteria

Sex
ALL
Age
0 Years - 6 Years
Healthy Volunteers
Not accepted

Interventions

  • EXPAREL — DRUG
    A single dose of EXPAREL Injectable Product via LIA
  • bupivacaine — DRUG
    A single dose of 0.25% bupivacaine via LIA

Study Details

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).

Key Dates

Start date
Mar 29, 2024
Status verified
Nov 2025
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027

Study Design

Enrollment
48 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: EXPAREL
    A total of approximately 24 subjects (8 subjects per Part) will be enrolled. Subjects in this arm will receive EXPAREL
  • Active Comparator: bupivacaine
    A total of approximately 24 subjects (8 subjects per Part) will be enrolled. Subjects in this arm will receive bupivacaine

Primary Outcome Measure

The following model-predicted PK endpoint will be determined: [ Time Frame: through 72 hours ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Indiana University Health, Riley Hospital For ChildrenIndianapolisIndiana46202
Stephanie Creamean
[email protected]
7657208423
St. Louis Children's Hospital (SLCH)St LouisMissouri63110
Kyle Stumbaugh
[email protected]
314-747-0707
Duke University Health SystemDurhamNorth Carolina27710
Amy Patrylick
[email protected]
919-681-2217
University of Oklahoma (OU) - Medical Center - The Children's HospitalOklahoma CityOklahoma73104
Amir L Butt, MD, MPH
[email protected]
(405) 271-8001
The University of Texas Health Science Center at Houston (UTHSC-H) - McGovern Medical SchoolHoustonTexas77030
Emad Sorial
[email protected]
713-500-6186

Find similar trials in Indianapolis, IN

By research site
Indiana University Health, Riley Hospital For Children· Indianapolis, INSt. Louis Children's Hospital (SLCH)· St Louis, MODuke University Health System· Durham, NCUniversity of Oklahoma (OU) - Medical Center - The Children's Hospital· Oklahoma City, OKThe University of Texas Health Science Center at Houston (UTHSC-H) - McGovern Medical School· Houston, TX

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