NCT06274008

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
96

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 12, 2023

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

November 3, 2023

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 23, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

February 23, 2024

Status Verified

February 1, 2024

Enrollment Period

1.1 years

First QC Date

November 3, 2023

Last Update Submit

February 21, 2024

Conditions

ACL TearOpioid MisusePainAnxiety

Outcome Measures

Primary Outcomes (1)

  • At-home narcotic consumption by the patients as measured by the medication form completed by parents post discharge

    Amount administered

    Postoperative days 1-3, 7, and 14.

Secondary Outcomes (4)

  • Postoperative pain level of child

    Postoperative days 1-3, 7, and 14.

  • Functional disability of child

    Baseline, Postoperative days 1-3, 7, and 14.

  • Parent and child anxiety

    Baseline, Postoperative days 1-3, 7, and 14.

  • Child pain

    Postoperative days 1-3, 7, and 14.

Study Arms (2)

Exparel

EXPERIMENTAL

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

Drug: Exparel

Standard ACB with bupivacaine

NO INTERVENTION

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

Interventions

ExparelDRUG

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

Exparel

Eligibility Criteria

Age7 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHOC Children's Hospital

Orange, California, 92868, United States

RECRUITING

Related Publications (1)

  • 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.

    PMID: 23298996BACKGROUND

MeSH Terms

Conditions

Anterior Cruciate Ligament InjuriesOpioid-Related DisordersPainAnxiety Disorders

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and InjuriesNarcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Haydee Cortes

CONTACT

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

Kiran Athreya

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 3, 2023

First Posted

February 23, 2024

Study Start

October 12, 2023

Primary Completion

October 30, 2024

Study Completion

December 31, 2024

Last Updated

February 23, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)