What is the mechanism of action of this treatment?

Common treatments for Total Knee Arthroplasty (TKA) include general anesthesia, neuraxial anesthesia, and localized nerve blocks such as genicular nerve block and anterior femoral cutaneous nerve block. General anesthesia induces a reversible loss of consciousness, while neuraxial anesthesia (e.g., spinal or epidural) blocks nerve signal transmission in the lower body, reducing pain and improving postoperative outcomes. Localized nerve blocks, like the genicular and anterior femoral cutaneous nerve blocks, work by interrupting nerve signal transmission at specific sites, providing targeted pain relief and potentially reducing the need for systemic opioids. Understanding these mechanisms is crucial for TKA patients as it helps in selecting the most appropriate pain management strategy, minimizing side effects, and enhancing recovery.

What side effects are associated with this type of intervention?

Common treatments for Total Knee Arthroplasty (TKA) include general anesthesia, spinal anesthesia, and localized nerve blocks such as the Genicular Nerve Block and Anterior Femoral Cutaneous Nerve Block. Side effects of these localized nerve blocks can include temporary numbness, weakness, or pain at the injection site, and in rare cases, infection or nerve damage. Additionally, patients may experience a reduction in opioid consumption and pain scores postoperatively, but these benefits must be weighed against the potential for localized adverse effects.

What prior FDA approvals exist?

The provided context does not include specific information on prior FDA approvals or related drugs for the treatment of Total Knee Arthroplasty using genicular nerve block and anterior femoral cutaneous nerve block. However, these techniques involve localized anesthesia by interrupting nerve signal transmission, which is a common approach in pain management for TKA. Generally, treatments for TKA pain management may include various forms of regional anesthesia, such as spinal or epidural anesthesia, and nerve blocks, which are used to reduce postoperative pain and opioid consumption.

What other types of research exist?

Promising novel alternatives to Genicular Nerve Block and Anterior Femoral Cutaneous Nerve Block for TKA patients include: 1) Continuous Peripheral Nerve Blocks (CPNB), which provide prolonged pain relief by continuously infusing local anesthetics near the nerve. 2) Liposomal Bupivacaine, a long-acting local anesthetic that can provide extended postoperative pain relief. 3) Cryoneurolysis, a technique that uses extreme cold to temporarily disrupt nerve function, offering pain relief for several weeks. 4) Peripheral Nerve Stimulation (PNS), which involves implanting a small device to deliver electrical impulses to the nerves, reducing pain perception.

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Procedure

Nerve Blocks for Knee Replacement Surgery

Phase 4

Recruiting

Led By Jiabin Liu, MD/PhD

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 in the post-operative care unit (pacu), up to 24 hours after surgery end and at 7 days after the day of surgery

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing if adding two specific nerve blocks to the usual pain management can better control pain and reduce the need for opioids in patients having knee replacement surgery. The study aims to see if this approach helps with pain relief and quicker recovery.

Who is the study for?

This trial is for adults aged 18-80 undergoing knee replacement surgery without chronic opioid use, severe kidney disease, allergies to local anesthetics or study drugs, neurological deficits, or certain other health issues. They must have a BMI under 35 and not be on anticonvulsants.

What is being tested?

The study tests if adding genicular and anterior femoral cutaneous nerve blocks to standard care reduces pain and opioid use after knee surgery. Participants are randomly assigned to receive these nerve blocks or not as part of their post-surgery care.

What are the potential side effects?

Possible side effects from the injections include pain at the injection site, infection risk, allergic reactions to the medications used (Fentanyl, Mepivacaine), and potential impacts on nerve function.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ in the post-operative care unit (pacu), up to 24 hours after surgery end and at 7 days after the day of surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~in the post-operative care unit (pacu), up to 24 hours after surgery end and at 7 days after the day of surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and in the post-operative care unit (pacu), up to 24 hours after surgery end and at 7 days after the day of surgery for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Bang Blinding Index

Brief Pain Inventory (short form)

Cumulative opioid consumption

+3 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 Genicular TKAExperimental Treatment4 Interventions

The genicular group will receive the study intervention of a genicular nerve block and anterior femoral cutaneous nerve block. The intervention group (genicular nerve block/anterior femoral cutaneous nerve block) will receive additional nerve blocks totaling 30 ml of 0.25% bupivacaine with 4 mg preservative-free dexamethasone (5 ml for each block: SMGN, IMGN, SLGN, NVI; 10ml for AFCN). The genicular group will be given 2-5 mg of intravenous midazolam and up to 100 mcg fentanyl for sedation and analgesia while the peripheral nerve blocks and spinal anesthesia are being performed. All patients will receive a spinal anesthetic (1.5% mepivacaine 52.5 - 60mg) and the standard adductor canal block and infiltration between the popliteal artery and posterior knee capsule block (20 ml of 0.25% bupivacaine with 2 mg preservative free dexamethasone for each block).

Group II: Group 1 Standard TKAActive Control1 Intervention

The standard TKA group will receive the standard of care analgesia. Those in the control group will be given 7 mg of the preservative dexamethasone intravenously. The standard group will be given 2-5 mg of intravenous midazolam and up to 100 mcg fentanyl for sedation and analgesia while the peripheral nerve blocks and spinal anesthesia are being performed. All patients will receive a spinal anesthetic (1.5% mepivacaine 52.5 - 60mg) as well as the standard adductor canal block and infiltration between the popliteal artery and posterior knee capsule block (20 ml of 0.25% bupivacaine with 2 mg preservative free dexamethasone for each block).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fentanyl

2019

Completed Phase 4

~1920

Mepivacaine

2013

Completed Phase 4

~23710

Bupivacaine Injection

2017

Completed Phase 4

~580

Dexamethasone injection

2019

Completed Phase 4

~390

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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 Total Knee Arthroplasty (TKA) include general anesthesia, neuraxial anesthesia, and localized nerve blocks such as genicular nerve block and anterior femoral cutaneous nerve block. General anesthesia induces a reversible loss of consciousness, while neuraxial anesthesia (e.g., spinal or epidural) blocks nerve signal transmission in the lower body, reducing pain and improving postoperative outcomes. Localized nerve blocks, like the genicular and anterior femoral cutaneous nerve blocks, work by interrupting nerve signal transmission at specific sites, providing targeted pain relief and potentially reducing the need for systemic opioids. Understanding these mechanisms is crucial for TKA patients as it helps in selecting the most appropriate pain management strategy, minimizing side effects, and enhancing recovery.