RECRUITING

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

Conditions

Postoperative Pain Analgesia Cardiac Surgery Pediatric

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

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

Quick Facts

Study Start:2024-03-29

Study Completion:2025-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06271265

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:0 Years to 6 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion Criteria
1. Parent/guardian able to speak, read, and understand the language of the ICF and provide informed consent for the subject. 2. American Society of Anesthesiologists (ASA) Class 1-3. 3. Male or female subjects from 0 to less than 6 years of age on the day of surgery. For Part 1, the subject's age should be 2 years to less than 6 years. For Part 2, the subject's age should be 6 months to less than 2 years. For Part 3, the subject's age should be 0 to less than 6 months. 4. Parent/guardian able to adhere to the study visit schedule and complete all study assessments for the subject.	1. History of hypersensitivity or idiosyncratic reactions or contradictions to bupivacaine HCl or other amide-type local anesthetics or to opioid medications. 2. Administration of EXPAREL or bupivacaine HCl within 30 days prior to study drug administration. 3. History of coagulopathies or immunodeficiency disorders. 4. Clinically significant medical or psychiatric disease that, in the opinion of the investigator, indicates an increased vulnerability to study drugs and/or procedures. 5. History of pre-term birth (babies born before 37 weeks of pregnancy). 6. Administration of an investigational drug within 30 days or 5 elimination half-lives of such investigational drug, whichever is longer, prior to study drug administration, or planned administration of another investigational product or procedure during the subject's participation in this study. 7. Concern about a subject's recent or potential exposure to COVID-19, or if the subject is not medically fit/cleared for surgery due to suspected COVID-19 illness/symptoms (or other serious illness).

Inclusion Criteria

Exclusion Criteria

1. Parent/guardian able to speak, read, and understand the language of the ICF and provide informed consent for the subject.
2. American Society of Anesthesiologists (ASA) Class 1-3.
3. Male or female subjects from 0 to less than 6 years of age on the day of surgery. For Part 1, the subject's age should be 2 years to less than 6 years. For Part 2, the subject's age should be 6 months to less than 2 years. For Part 3, the subject's age should be 0 to less than 6 months.
4. Parent/guardian able to adhere to the study visit schedule and complete all study assessments for the subject.

1. History of hypersensitivity or idiosyncratic reactions or contradictions to bupivacaine HCl or other amide-type local anesthetics or to opioid medications.
2. Administration of EXPAREL or bupivacaine HCl within 30 days prior to study drug administration.
3. History of coagulopathies or immunodeficiency disorders.
4. Clinically significant medical or psychiatric disease that, in the opinion of the investigator, indicates an increased vulnerability to study drugs and/or procedures.
5. History of pre-term birth (babies born before 37 weeks of pregnancy).
6. Administration of an investigational drug within 30 days or 5 elimination half-lives of such investigational drug, whichever is longer, prior to study drug administration, or planned administration of another investigational product or procedure during the subject's participation in this study.
7. Concern about a subject's recent or potential exposure to COVID-19, or if the subject is not medically fit/cleared for surgery due to suspected COVID-19 illness/symptoms (or other serious illness).

Contacts and Locations

Study Contact

Sarah Shaffer

CONTACT

973-451-4071

sarah.shaffer@pacira.com

Study Locations (Sites)

Duke University Health System

Durham, North Carolina, 27710

United States

University of Oklahoma (OU) - Medical Center - The Children's Hospital

Oklahoma City, Oklahoma, 73104

United States

The University of Texas Health Science Center at Houston (UTHSC-H) - McGovern Medical School

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: Pacira Pharmaceuticals, Inc

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-29

Study Completion Date2025-07

Study Record Updates

Study Start Date2024-03-29

Study Completion Date2025-07

Terms related to this study

Keywords Provided by Researchers

Analgesia
Cardiac Surgery
Pediatric

Additional Relevant MeSH Terms

Postoperative Pain