What side effects are associated with this type of intervention?

Common treatments for Anterior Cruciate Ligament (ACL) injury, such as genicular nerve blocks, multimodal analgesia, and cryotherapy, have various side effects. Nerve blocks can cause temporary numbness, leg weakness, and potential nerve damage. NSAIDs and corticosteroids, used in multimodal analgesia, may lead to gastrointestinal issues, increased blood pressure, and kidney damage. Cryotherapy can result in skin irritation or frostbite if not applied correctly.

What prior FDA approvals exist?

There is limited specific information on FDA approvals for treatments directly targeting ACL injuries using nerve blocks like the genicular nerve block. However, nerve blocks, including adductor canal blocks and femoral nerve blocks, are commonly used for pain management in knee surgeries, including ACL reconstruction. These methods are part of multimodal analgesia approaches that may include local anesthetics, NSAIDs, and corticosteroids. While genicular nerve blocks are being studied for their efficacy in reducing opioid consumption and improving pain management post-ACL surgery, specific FDA approvals for this exact application are not detailed.

What other types of research exist?

Promising novel alternatives to Genicular Nerve Block for ACL injury patients include: 1) Adductor Canal Block (ACB) combined with IPACK (Interspace between the Popliteal Artery and the Capsule of the posterior Knee) block, which has shown enhanced postoperative pain control. 2) Continuous femoral nerve block, which provides effective analgesia and supports functional recovery. 3) Platelet-Rich Plasma (PRP) therapy, which may aid in tissue healing and reduce recovery time. 4) Low-intensity pulsed ultrasound, which has been noted to accelerate ligament healing. These alternatives should be discussed with a healthcare provider to determine the best individualized treatment plan.

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Genicular Nerve Block for ACL Surgery

Phase 4

Recruiting

Led By David H Kim, MD

Research Sponsored by Hospital for Special Surgery, New York

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up sum of opioid used from 0-24 hours, 0-48 hours, and 0-72 hours, 0-96 hours, and 0-168 hours post-operative

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing a new pain relief method by adding a specific type of nerve numbing to the usual methods for patients having ACL repair surgery. The goal is to see if this can reduce pain, lessen the need for strong painkillers, and help patients recover faster by numbing specific nerves in the knee. This nerve numbing technique has recently emerged as a new alternative treatment for chronic knee pain and has been used in various studies to alleviate pain and improve knee functionality.

Who is the study for?

This trial is for adults aged 18-80 with a BMI under 35, scheduled for ACL knee surgery using their own tissue grafts. They must speak English and have an ASA classification of I-III, indicating they're healthy or have mild to moderate systemic disease. People can't join if they use opioids daily, have chronic pain syndromes, substance abuse history, allergies to local anesthetics or study drugs, psychiatric conditions affecting protocol adherence, infection at the injection site, or certain nerve issues.

What is being tested?

The trial tests whether adding genicular nerve blocks to standard peripheral nerve blocks reduces opioid use by one-third in the first day after ACL surgery. It also examines if this method lowers pain scores, speeds up discharge times from the hospital, provides over 24 hours of relief and improves overall pain management post-surgery.

What are the potential side effects?

Potential side effects may include discomfort at the injection site, allergic reactions to bupivacaine or dexamethasone used in genicular nerve blocks. There's also a risk of temporary numbness or weakness in the leg due to nerve blockage.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ sum of opioid used from 0-24 hours, 0-48 hours, and 0-72 hours, 0-96 hours, and 0-168 hours post-operative

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~sum of opioid used from 0-24 hours, 0-48 hours, and 0-72 hours, 0-96 hours, and 0-168 hours post-operative

This trial's timeline: 3 weeks for screening, Varies for treatment, and sum of opioid used from 0-24 hours, 0-48 hours, and 0-72 hours, 0-96 hours, and 0-168 hours post-operative for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mean Opioid Consumption at 24 hours

Secondary study objectives

Adverse events

Brief Pain Inventory

Cumulative opioid pills consumption

+7 more

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

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

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Group 2 - InterventionExperimental Treatment1 Intervention

Patients randomized to this group will receive an adductor canal block (ACB), Infiltration between the Popliteal Artery and Capsule of the Knee (IPACK) nerve block, and the genicular nerve block (intervention). The genicular nerve block is a total of 20cc of 0.25% bupivacaine with 2mg of preservative free dexamethasone applied to the superomedial genicular nerve, superolateral genicular nerve, inferomedial genicular nerve, and nerve to vastus intermedius.

Group II: Group 1 - ControlActive Control1 Intervention

Patients randomized to this group will receive an adductor canal block (ACB) and Infiltration between the Popliteal Artery and Capsule of the Knee (IPACK) nerve block.

Do I qualify?Apply below to find out

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

Common treatments for Anterior Cruciate Ligament (ACL) injury include nerve blocks, local infiltration analgesia, and multimodal analgesia. Genicular Nerve Block involves injecting anesthetics around the nerves supplying the knee joint to reduce pain by interrupting pain signal transmission. This method can significantly decrease opioid consumption and improve pain management, facilitating earlier discharge and better postoperative recovery. Local infiltration analgesia involves injecting anesthetics directly into the surgical site, providing localized pain relief. Multimodal analgesia combines various methods such as nerve blocks, NSAIDs, corticosteroids, and cryotherapy to manage pain through different mechanisms, enhancing overall pain control and reducing reliance on opioids. These treatments are crucial for ACL injury patients as they help manage postoperative pain effectively, promoting faster rehabilitation and improving functional outcomes.

Analgesic efficacy of local infiltration analgesia vs. femoral nerve block after anterior cruciate ligament reconstruction: a systematic review and meta-analysis.Anesthesia and analgesia methods for outpatient anterior cruciate ligament reconstruction.