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Tests treatment safety and results for Postoperative Pain
Official title Study to Evaluate the Pharmacokinetics and Safety of EXPAREL for Postoperative Analgesia in Subjects Undergoing Cardiac Surgery
ClinicalTrials.gov ID: NCT06271265
What this study is testing
What is EXPAREL?
EXPAREL is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for postoperative pain.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 0 to 6
You may be able to join if
- All of the following 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...
- 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.
You likely can't join if
- Exclusion Criteria: 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...
- 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...
- History of preterm birth (before 35 weeks of pregnancy)
- History of coagulopathies or immunodeficiency disorders
See the full eligibility criteria
- All of the following 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...
- 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.
- Exclusion Criteria: 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Indianapolis, Indiana, United States
- St Louis, Missouri, United States
- Durham, North Carolina, United States
- Oklahoma City, Oklahoma, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0 years to 6 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Indianapolis, Indiana, United States; St Louis, Missouri, United States; Durham, North Carolina, United States; Oklahoma City, Oklahoma, United States; Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.