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Local Anesthetic

EXPAREL for Postoperative Pain

Phase 1
Recruiting
Research Sponsored by Pacira Pharmaceuticals, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 ± 3 days
Awards & highlights

Study Summary

This trial will compare the use of EXPAREL with bupivacaine in children under 6 years old who are having heart surgery. The study will look at how the drugs are processed by

Who is the study for?
This trial is for children aged 0 to less than 6 years undergoing cardiac surgery. Their guardians must understand the consent form and agree to follow the study's schedule. Children should be healthy enough for anesthesia (ASA Class 1-3). Different age groups will be studied in separate parts of the trial.Check my eligibility
What is being tested?
The study compares EXPAREL, a long-lasting pain reliever, with bupivacaine, a common local anesthetic, in young patients after heart surgery. It aims to see how these drugs are processed by the body and how safe they are when used for pain control.See study design
What are the potential side effects?
Possible side effects may include reactions at the injection site, nausea, vomiting, fever or chills. Since it involves anesthesia-related drugs in children post-surgery, close monitoring is essential.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 ± 3 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 ± 3 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The following model-predicted PK endpoint will be determined
Secondary outcome measures
Incidence of adverse events of special interest (AESIs)
Incidence of serious adverse events (SAEs)
Incidence of treatment-emergent adverse events (TEAEs)
+1 more

Side effects data

From 2015 Phase 4 trial • 12 Patients • NCT02199574
8%
rash
8%
pyrexia
100%
80%
60%
40%
20%
0%
Study treatment Arm
EXPAREL

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: EXPARELExperimental Treatment1 Intervention
A total of approximately 24 subjects (8 subjects per Part) will be enrolled. Subjects in this arm will receive EXPAREL
Group II: bupivacaineActive Control1 Intervention
A total of approximately 24 subjects (8 subjects per Part) will be enrolled. Subjects in this arm will receive bupivacaine
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
EXPAREL
2014
Completed Phase 4
~1140

Find a Location

Who is running the clinical trial?

Pacira Pharmaceuticals, IncLead Sponsor
136 Previous Clinical Trials
13,933 Total Patients Enrolled
16 Trials studying Postoperative Pain
1,491 Patients Enrolled for Postoperative Pain
~32 spots leftby Jul 2025
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