Exparel vs. ACB With Bupivacaine for ACL Reconstruction

NCT ID: NCT06274008

Last Updated: 2024-02-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-12
• Study Completion Date: 2024-12-31

Brief 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.

Detailed 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.

Conditions

ACL Tear; Opioid Misuse; Pain; Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Exparel

Adductor Canal Block with Bupivacaine Liposome Injectable Suspension Admixture bupivacaine 0.5 % 10 cc with Bupivacaine Liposome Injectable Suspension 10cc total 20

Group Type: EXPERIMENTAL

Exparel

Intervention Type: DRUG

Admixture bupivacaine 0.5 % 10 cc with Bupivacaine Liposome Injectable Suspension 10cc total 20

Standard ACB with bupivacaine

Standard Adductor Canal Block (ACB) with Bupivacaine Standardized amount of 0.5% bupivacaine 20 cc

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Exparel

Admixture bupivacaine 0.5 % 10 cc with Bupivacaine Liposome Injectable Suspension 10cc total 20

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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).
• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Surgery scheduled between the hours of 8am - 4pm

Exclusion Criteria

• No prior major surgery (e.g. transplant procedures, cardiac, cranial surgeries)
• 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.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Children's Hospital of Orange County

OTHER

Sponsor Role: lead

Responsible Party

John Schlechter

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

CHOC Children's Hospital

Orange, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Haydee Cortes

Role: CONTACT

haydee.cortes@choc.org

714-456-2837

Kiran Athreya

Role: CONTACT

kiran.athreya@choc.org

949-306-4857

Facility Contacts

Haydee Cortes

Role: primary

haydee.cortes@choc.org

714-456-2837

Kiran Athreya

Role: backup

kiran.athreya@choc.org

9493064857

References

McCabe SE, West BT, Boyd CJ. Leftover prescription opioids and nonmedical use among high school seniors: a multi-cohort national study. J Adolesc Health. 2013 Apr;52(4):480-5. doi: 10.1016/j.jadohealth.2012.08.007. Epub 2012 Nov 22.

Reference Type: BACKGROUND

PMID: 23298996 (View on PubMed)

Other Identifiers

230110

Identifier Type: -

Identifier Source: org_study_id