Recruiting
Phase 1

Exparel vs. ACB

Sponsor:

Children's Hospital of Orange County

Code:

NCT06274008

Conditions

ACL Tear

Opioid Misuse

Pain

Anxiety

Eligibility Criteria

Sex: All

Age: 7 - 17

Healthy Volunteers: Accepted

Interventions

Exparel

Study Details

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.

Conditions

ACL Tear

Opioid Misuse

Pain

Anxiety

Study ID

NCT06274008

Start date

Oct 12, 2023

Status verified date

Feb, 2024

Completion date

Dec 31, 2024

Anticipated

Primary completion date

Oct 30, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 7 - 17

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

96 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Exparel

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

no intervention: Standard ACB with bupivacaine

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

Interventions

Exparel

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

Primary outcome measure

  • At-home narcotic consumption by the patients as measured by the medication form completed by parents post discharge [ Time Frame: Postoperative days 1-3, 7, and 14. ]

Central Contacts and Locations

Central contacts

Haydee Cortes

714-456-2837haydee.cortes@choc.org

Kiran Athreya

949-306-4857kiran.athreya@choc.org

Locations

CHOC Children's Hospital

Recruiting

Orange, California, United States, 92868

Contacts

Haydee Cortes

714-456-2837haydee.cortes@choc.org

Kiran Athreya

9493064857kiran.athreya@choc.org

Principal Investigator:

John Schlechter, DO

More Information

Sponsor

Children's Hospital of Orange County

Last update posted

Feb 23, 2024

Last verified

Feb, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's Hospital of Orange County on 2024-02-23.