A Phase 1 interventional study of EXPAREL and bupivacaine in Postoperative Pain, sponsored by Pacira Pharmaceuticals, Inc. Recruiting at 5 sites in United States. Open to participants aged 0 Years to 6 Years. Per ClinicalTrials.gov, last updated 2025-12-29.
Sponsored by Pacira Pharmaceuticals, Inc · Phase 1, Interventional, and Treatment
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).
This study will be conducted in 3 Parts (Part 1, Part 2, and Part 3) and a total of approximately 48 male and female subjects will be enrolled.
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.
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
This study's planned enrollment of 48 is below the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Pacira Pharmaceuticals, Inc is the lead sponsor of 102 studies on the registry; 3 are open to participants now.
Of its 26 completed or terminated interventional studies of FDA-regulated products, 17 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
All of the following inclusion criteria must be met for eligibility:
Exclusion Criteria:
Exclusion Criteria:
A participant will not be eligible for the study if any of the following exclusion criteria are met:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A total of approximately 24 subjects (8 subjects per Part) will be enrolled. Subjects in this arm will receive EXPAREL
Drug: EXPAREL
A total of approximately 24 subjects (8 subjects per Part) will be enrolled. Subjects in this arm will receive bupivacaine
Drug: bupivacaine
A single dose of EXPAREL Injectable Product via LIA
A single dose of 0.25% bupivacaine via LIA
The following model-predicted PK endpoint will be determined:
• Area under the plasma concentration-versus-time curve (AUClast and AUC0-inf)
Time frame: through 72 hours
The following model-predicted PK endpoint will be determined:
• Maximum observed plasma concentration (Cmax)
Time frame: through 72 hours
The following model-predicted PK endpoint will be determined:
• Time of maximum observed plasma concentration (Tmax)
Time frame: through 72 hours
The following model-predicted PK endpoint will be determined:
• The apparent terminal elimination half-life (t1/2)
Time frame: through 72 hours
The following model-predicted PK endpoint will be determined:
• Apparent clearance (CL)
Time frame: through 72 hours
The following model-predicted PK endpoint will be determined:
• Apparent volume of distribution (Vd)
Time frame: through 72 hours
Vitals change from Baseline:
temperature
Time frame: up to 4 postoperative days
Vitals change from Baseline:
heart rate
Time frame: up to 4 postoperative days
Vitals change from Baseline:
respiratory rate
Time frame: up to 4 postoperative days
Vitals change from Baseline:
oxygen saturation
Time frame: up to 4 postoperative days
Vitals change from Baseline:
blood pressure
Time frame: up to 4 postoperative days
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: 14 ± 3 days
Incidence of adverse events of special interest (AESIs)
Time frame: 14 ± 3 days
Incidence of serious adverse events (SAEs)
Time frame: 14 ± 3 days
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Studies of the drug tested here: Liposomal Bupivacaine