Back to search results

EXPAREL for Postoperative Pain in Children Undergoing Cardiac Surgery

This study is looking at how the pain medication EXPAREL works in children aged 0 to less than 6 years old who are having heart surgery. Researchers want to understand how the body processes EXPAREL (pharmacokinetics) and if it's safe, compared to another pain medication called bupivacaine. Both medications are given directly into the surgical area (local infiltration analgesia or LIA). The study will enroll about 48 children in total. Success in this study means understanding how EXPAREL is absorbed, distributed, metabolized, and excreted by the body, and if it is safe for these young patients. The current recruitment status is unclear.

Study design
This is a Phase 1, multicenter, open-label, randomized study comparing EXPAREL to bupivacaine. Approximately 48 participants will be enrolled across three parts.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 72 hours to measure how the body processes the medication.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06271265

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

Recruiting
PHASE1Ages 0–6InterventionalTreatment
Pacira Pharmaceuticals, Inc
~48 participants
Updated 2025-12-29 on ClinicalTrials.gov
What's tested:EXPARELbupivacaine

At a glance

Recruiting sites
5 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The following model-predicted PK endpoint will be determined:
Measured over through 72 hours
+5 more outcomes measured

Conditions

Postoperative Pain

Explore related trials

Heart MalformationPost-Operative Pain

Where it's being run

5 sites across 5 states
Indiana1
Missouri1
North Carolina1
Oklahoma1
Texas1

Who to contact

Sarah Shaffer
[email protected]
973-451-4071
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

What this trial measures

  • The following model-predicted PK endpoint will be determined:through 72 hours

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

  • The following model-predicted PK endpoint will be determined:through 72 hours

    • Maximum observed plasma concentration (Cmax)

  • The following model-predicted PK endpoint will be determined:through 72 hours

    • Time of maximum observed plasma concentration (Tmax)

  • The following model-predicted PK endpoint will be determined:through 72 hours

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

  • The following model-predicted PK endpoint will be determined:through 72 hours

    • Apparent clearance (CL)

  • The following model-predicted PK endpoint will be determined:through 72 hours

    • Apparent volume of distribution (Vd)