RECRUITING

Exparel vs. ACB With Bupivacaine for ACL Reconstruction

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

Opioid misuse and addiction among children and adolescents is an increasingly concerning problem. Post-surgical opioid prescriptions for commonly performed surgeries such as anterior cruciate ligament reconstruction (ACLR) increase opioid exposure in young athletes. The purpose of the current study is to determine if extended-release Bupivacaine Liposome Injectable Suspension (Exparel) is effective in decreasing at home narcotic consumption compared to standard Bupivacaine Adductor Canal Block for Anterior Cruciate Ligament (ACL) reconstruction/reconstruction for the surgical treatment of adolescents with ACL tears and concomitant pathology i.e. meniscus / cartilage injury/tear.

Official Title

Prospective Randomized Trial (RCT) of Adductor Canal Block With Bupivacaine Liposome Injectable Suspension (Exparel) for Anterior Cruciate Ligament Reconstruction vs. Standard Adductor Canal Block (ACB) With Bupivacaine

Quick Facts

Study Start:2023-10-12
Study Completion:2024-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06274008

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:7 Years to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Patients who are 7-17 years old undergoing elective ACL reconstruction/repair with American Society of Anesthesiologists (ASA) Classification 1-2 at Children's Hospital of Orange County (CHOC).
  2. * Provision of signed and dated informed consent form
  3. * Stated willingness to comply with all study procedures and availability for the duration of the study
  4. * Surgery scheduled between the hours of 8am - 4pm
  1. * No prior major surgery (e.g. transplant procedures, cardiac, cranial surgeries)
  2. * Learning disability or developmental delay. Learning disability or developmental delay will have been assessed by an outside specialist. Diagnosis will have either been communicated to attending physician by the patient or will be located in patient's medical record. Anything that would impede survey completion.

Contacts and Locations

Study Contact

Haydee Cortes
CONTACT
714-456-2837
haydee.cortes@choc.org
Kiran Athreya
CONTACT
949-306-4857
kiran.athreya@choc.org

Study Locations (Sites)

CHOC Children's Hospital
Orange, California, 92868
United States

Collaborators and Investigators

Sponsor: Children's Hospital of Orange County

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 Date2023-10-12
Study Completion Date2024-12-31

Study Record Updates

Study Start Date2023-10-12
Study Completion Date2024-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • ACL Tear
  • Opioid Misuse
  • Pain
  • Anxiety