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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 belowSelect...
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.
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 moreTrial 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
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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
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