Postoperative PainPhase 1NCT06271265
Study to Evaluate the Pharmacokinetics and Safety of EXPAREL for Postoperative Analgesia in Subjects Undergoing Cardiac Surgery
A Phase 1 study testing EXPAREL and bupivacaine in people with Postoperative Pain, run by Pacira Pharmaceuticals, Inc at 5 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 0 to 6 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- EXPAREL and bupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 5 sitesUnited States
- Study dates
- 29 Mar 2024to Jan 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All of the following inclusion criteria must be met for eligibility:
- 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.
Who cannot join
- A participant will not be eligible for the study if any of the following exclusion criteria are met:
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Duke University Health System
Durham, North Carolina, 27710
Amy Patrylick, 919-681-2217, amy.petrylick@duke.edu
- Recruiting
The University of Texas Health Science Center at Houston (UTHSC-H) - McGovern Medical School
Houston, Texas, 77030
Emad Sorial, 713-500-6186, Emad.M.Sorial@uth.tmc.edu
- Recruiting
Indiana University Health, Riley Hospital For Children
Indianapolis, Indiana, 46202
Stephanie Creamean, 7657208423, stephac1@iu.edu
- Recruiting
University of Oklahoma (OU) - Medical Center - The Children's Hospital
Oklahoma City, Oklahoma, 73104
Amir L Butt, MD, MPH, (405) 271-8001 ext. 36017, abutt@ouhsc.edu
- Recruiting
St. Louis Children's Hospital (SLCH)
St Louis, Missouri, 63110
Kyle Stumbaugh, 314-747-0707, kyles@wustl.edu
About this study
Official title: A Multicenter, Open-label, Randomized, Bupivacaine-Controlled Study to Evaluate the Pharmacokinetics and Safety of EXPAREL for Postoperative Analgesia in Subjects Aged 0 to Less Than 6 Years Undergoing Cardiac Surgery
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).
Read the detailed description
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.
- Conditions
- Postoperative Pain
- Being tested
- EXPAREL, bupivacaine
- Keywords
- Analgesia, Cardiac Surgery, Pediatric
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EXPARELDrug
A single dose of EXPAREL Injectable Product via LIA
bupivacaineDrug
A single dose of 0.25% bupivacaine via LIA
| Study group | Role | What they receive |
|---|---|---|
| EXPAREL | Experimental | A total of approximately 24 subjects (8 subjects per Part) will be enrolled. Subjects in this arm will receive EXPAREL Receives: 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 Receives: Drug: bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The following model-predicted PK endpoint will be determined:
- Area under the plasma concentration-versus-time curve (AUClast and AUC0-inf)
Measured: through 72 hours
The following model-predicted PK endpoint will be determined:
- Maximum observed plasma concentration (Cmax)
Measured: through 72 hours
The following model-predicted PK endpoint will be determined:
- Time of maximum observed plasma concentration (Tmax)
Measured: through 72 hours
The following model-predicted PK endpoint will be determined:
- The apparent terminal elimination half-life (t1/2)
Measured: through 72 hours
The following model-predicted PK endpoint will be determined:
- Apparent clearance (CL)
Measured: through 72 hours
The following model-predicted PK endpoint will be determined:
- Apparent volume of distribution (Vd)
Measured: through 72 hours
Secondary outcomes (8)
Vitals change from Baseline:
temperature
Measured: up to 4 postoperative days
Vitals change from Baseline:
heart rate
Measured: up to 4 postoperative days
Vitals change from Baseline:
respiratory rate
Measured: up to 4 postoperative days
Vitals change from Baseline:
oxygen saturation
Measured: up to 4 postoperative days
Vitals change from Baseline:
blood pressure
Measured: up to 4 postoperative days
Incidence of treatment-emergent adverse events (TEAEs)
Measured: 14 ± 3 days
Incidence of adverse events of special interest (AESIs)
Measured: 14 ± 3 days
Incidence of serious adverse events (SAEs)
Measured: 14 ± 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start29 Mar 2024
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pacira Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06271265
- Sponsor's protocol ID
- 402-C-125
- Status last verified
- Nov 2025
- First submitted
- 18 Jan 2024
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Randomized, Bupivacaine-Controlled Study to Evaluate the Pharmacokinetics and Safety of EXPAREL for Postoperative Analgesia in Subjects Aged 0 to Less Than 6 Years Undergoing Cardiac Surgery
- ClinicalTrials.gov ID
- NCT06271265
- Acronym / sponsor ID
- 402-C-125
- Conditions
- Postoperative Pain
- Keywords
- Analgesia, Cardiac Surgery, Pediatric
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Pacira Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- 29 Mar 2024 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 21 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EXPAREL | Experimental | Drug: EXPARELA total of approximately 24 subjects (8 subjects per Part) will be enrolled. Subjects in this arm will receive EXPAREL |
| bupivacaine | Active comparator | Drug: bupivacaineA total of approximately 24 subjects (8 subjects per Part) will be enrolled. Subjects in this arm will receive bupivacaine |
Who may qualify
- Ages
- 0 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- A participant will not be eligible for the study if any of the following exclusion criteria are met:
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EXPARELA single dose of EXPAREL Injectable Product via LIA | Drug | EXPAREL |
| bupivacaineA single dose of 0.25% bupivacaine via LIA | Drug | bupivacaine |
Primary outcome
The following model-predicted PK endpoint will be determined:
Time frame: through 72 hours
• Area under the plasma concentration-versus-time curve (AUClast and AUC0-inf)
The following model-predicted PK endpoint will be determined:
Time frame: through 72 hours
• Maximum observed plasma concentration (Cmax)
The following model-predicted PK endpoint will be determined:
Time frame: through 72 hours
• Time of maximum observed plasma concentration (Tmax)
The following model-predicted PK endpoint will be determined:
Time frame: through 72 hours
• The apparent terminal elimination half-life (t1/2)
The following model-predicted PK endpoint will be determined:
Time frame: through 72 hours
• Apparent clearance (CL)
The following model-predicted PK endpoint will be determined:
Time frame: through 72 hours
• Apparent volume of distribution (Vd)
8 secondary outcomes
Vitals change from Baseline:
Time frame: up to 4 postoperative days
Vitals change from Baseline:
Time frame: up to 4 postoperative days
Vitals change from Baseline:
Time frame: up to 4 postoperative days
Vitals change from Baseline:
Time frame: up to 4 postoperative days
Vitals change from Baseline:
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EXPAREL and bupivacaine in people with Postoperative Pain, run by Pacira Pharmaceuticals, Inc at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah Shaffer (973-451-4071, sarah.shaffer@pacira.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The following model-predicted PK endpoint will be determined: (time frame: through 72 hours). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2025.