What side effects are associated with this type of intervention?

Common treatments for pain, particularly those similar to Extended-release Bupivacaine Liposome Injectable Suspension (Exparel), include local anesthetics and opioid analgesics. Local anesthetics like bupivacaine can cause numbness, tingling, and in rare cases, systemic toxicity affecting the cardiovascular and central nervous systems. Opioid analgesics, often used alongside local anesthetics, can lead to nausea, vomiting, constipation, drowsiness, and a risk of addiction and misuse. The goal of combining these treatments is to reduce opioid consumption and minimize their associated side effects.

What prior FDA approvals exist?

Extended-release Bupivacaine Liposome Injectable Suspension (Exparel) is designed to provide prolonged local anesthetic effects, reducing postoperative pain and the need for narcotics. Similar FDA-approved treatments include standard Bupivacaine formulations used in nerve blocks and other local anesthetics like Ropivacaine. These agents are often employed in various surgical procedures to manage pain effectively while minimizing opioid consumption. Additionally, adjuvant therapies such as continuous femoral nerve blocks and periarticular injections with local anesthetics have been explored to enhance pain control and functional recovery post-surgery.

What other types of research exist?

One promising alternative to Exparel is the use of continuous femoral nerve blocks, which have been shown to provide improved analgesia with fewer side effects compared to systemic opioids. Additionally, adductor canal blocks have been found to be effective in providing pain relief and preserving quadriceps strength postoperatively. These techniques can be considered for pain management in 2024.

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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

No Placebo-Only Group

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 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

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 2Eligibility criteria met

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.