UnknownPhase 1

Exparel vs. ACB With Bupivacaine for ACL Reconstruction

United States96 participantsStarted 2023-10-12

Plain-language 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.

Who can participate

Age range7 Years – 17 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

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

Timeframe: Postoperative days 1-3, 7, and 14.

Trial details

NCT IDNCT06274008

SponsorChildren's Hospital of Orange County

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-10-30

Contact for this trial

Haydee Cortes

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