← Back to Search

Local Anesthetic

Exparel for Pain After ACL Surgery

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
Must not have
No prior major surgery (e.g. transplant procedures, cardiac, cranial surgeries)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up postoperative days 1-3, 7, and 14.
Awards & highlights

Summary

This trial is testing a long-lasting numbing injection called Exparel to help manage pain in teenagers after ACL surgery. The goal is to see if this injection can reduce the need for strong painkillers at home. By using Exparel, doctors hope to lower the risk of opioid misuse among young athletes.

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have not had any major surgeries like transplants or heart surgery.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
At-home narcotic consumption by the patients as measured by the medication form completed by parents post discharge
Secondary study objectives
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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Local anesthetics like Extended-release Bupivacaine Liposome Injectable Suspension (Exparel) work by blocking sodium channels in nerve cells, which prevents the transmission of pain signals. This prolonged local anesthetic effect can significantly reduce postoperative pain and decrease the need for narcotics, thereby minimizing the risk of opioid misuse and addiction. Multimodal analgesic regimens combine different types of pain relief methods, such as non-opioid medications and local anesthetics, to enhance pain control while reducing opioid consumption. Interventional therapies, including nerve blocks and epidural steroid injections, target specific pain generators to provide localized pain relief. These approaches are crucial for pain patients as they offer effective pain management while mitigating the adverse effects associated with long-term opioid use.
Reduced Opioid Use Among Patients Who Received Liposomal Bupivacaine for ACL Reconstruction.Evolving Role of Local Anesthetics in Managing Postsurgical Analgesia.

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
~8 spots leftby Oct 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top