Exparel vs. ACB With Bupivacaine for ACL Reconstruction

Last updated: February 21, 2024
Sponsor: Children's Hospital of Orange County
Overall Status: Active - Recruiting

Phase

1

Condition

Pain

Opioid Use Disorder

Treatment

Exparel

Clinical Study ID

NCT06274008
230110
  • Ages 7-17
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients who are 7-17 years old undergoing elective ACL reconstruction/repair withAmerican Society of Anesthesiologists (ASA) Classification 1-2 at Children's Hospitalof Orange County (CHOC).
  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for theduration of the study
  • Surgery scheduled between the hours of 8am - 4pm

Exclusion

Exclusion Criteria:

  • No prior major surgery (e.g. transplant procedures, cardiac, cranial surgeries)
  • Learning disability or developmental delay. Learning disability or developmental delaywill have been assessed by an outside specialist. Diagnosis will have either beencommunicated to attending physician by the patient or will be located in patient'smedical record. Anything that would impede survey completion.

Study Design

Total Participants: 96
Treatment Group(s): 1
Primary Treatment: Exparel
Phase: 1
Study Start date:
October 12, 2023
Estimated Completion Date:
December 31, 2024

Study Description

Approximately 13% of high school seniors have reported nonmedical use of prescription opioids in their lifetimes with 8.7% to 11% reporting use within the last year. The second most common source of opioids (36.9%) in this population is leftover medication from previous legitimate prescriptions after injury or procedures. Before injury or surgery, most children and adolescents are narcotic naive. Medical use of opioids in this population increases the risk for nonmedical opioid misuse after high school by 33% (1). As orthopaedic surgeons, the surgeons are in a powerful position to understand and affect change in the adolescent population through patient/parent education and through controlling the amount and type of pain medications prescribed. The investigators propose a Double Blinded RCT of adolescents with ACL +/- meniscus tear to either bupivacaine ACB or Bupivacaine Liposome Injectable Suspension ACB (Exparel) to test whether injectable suspension reduces at home narcotic consumption postoperatively. Currently there is limited data available for the pediatric population and no known randomized controlled trials. Bupivacaine Liposome Injectable Suspension is FDA approved for use in adults but has been used in this pediatric population off-label for many years. Exparel is now FDA approved and indicated for single-dose infiltration in patients aged 6 years and older to produce postsurgical local analgesia. While widely used in the settings of a regional block in adolescents undergoing ACL reconstruction and other surgeries, it does not have specific FDA approval for the use in blocks. This is not uncommon practice and in fact many of the drugs used in pediatrics do not have specific approval by the FDA(2).

After enrollment, the research subject will be randomized into one of two arms and the anesthesiologist will be notified of the arm. Data will be collected at baseline, on day of surgery, and on days 1 through 14 postoperatively. Participants will be instructed to wear Actigraphs in the days leading up to surgery to obtain baseline sleep activity data.

Connect with a study center

  • CHOC Children's Hospital

    Orange, California 92868
    United States

    Active - Recruiting

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