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Local Anesthetic

Exparel for Pain

Phase 1

Recruiting

Research Sponsored by Children's Hospital of Orange County

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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)

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up postoperative days 1-3, 7, and 14.

Awards & highlights

Study Summary

This trial aims to see if a specific type of pain medication called Exparel can help reduce the amount of narcotic pain medication needed after ACL surgery in teenagers.

Who is the study for?

This trial is for young athletes with ACL tears who may need surgery and are at risk of opioid misuse. Participants should not have a history of opioid abuse or dependency, and must be able to follow post-surgical care instructions.Check my eligibility

What is being tested?

The study tests if Exparel, an extended-release pain medication, can reduce the need for narcotics after ACL surgery compared to standard Bupivacaine. The goal is to see if Exparel can help manage pain effectively while lowering the risk of opioid use.See study design

What are the potential side effects?

Exparel may cause side effects such as nausea, constipation, vomiting, fever, and headache. There's also a chance of local reactions like swelling or itching where the drug was injected.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 7-17 years old, having ACL surgery at CHOC, and in good health.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ postoperative days 1-3, 7, and 14.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~postoperative days 1-3, 7, and 14.

This trial's timeline: 3 weeks for screening, Varies for treatment, and postoperative days 1-3, 7, and 14. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Child pain

Functional disability of child

Parent and child anxiety

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: ExparelExperimental Treatment1 Intervention

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

Group II: Standard ACB with bupivacaineActive Control1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Exparel

2014

Completed Phase 4

~1620

0 / 1Eligibility criteria met

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Children's Hospital of Orange CountyLead Sponsor

32 Previous Clinical Trials

4,838 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do I meet the requirements to participate in this research endeavor?

"Participants aged between 7 and 17 years with a documented anterior cruciate ligament tear are sought for this study, aiming to recruit approximately 96 individuals."

Answered by AI

Is this medical study actively seeking participants at the moment?

"As per the details furnished on clinicaltrials.gov, this investigation is actively pursuing potential participants. The trial was initially published on October 12th, 2023 and recently revised on February 21st, 2024."

Answered by AI

What is the current number of individuals being recruited for participation in this clinical research study?

"Indeed, the details available on clinicaltrials.gov indicate that this particular research study is actively in search of suitable candidates. Originally made public on October 12th, 2023 and subsequently revised on February 21st, 2024, the investigation aims to enroll a total of 96 participants from one designated site."

Answered by AI