Nerve Blocks for Knee Replacement Surgery

Overseen By Maya Tailor, BS

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Hospital for Special Surgery, New York

Must not be taking: Anticonvulsants

Disqualifiers: Chronic pain, Chronic opioid use, Neuropathy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether special nerve blocks can reduce pain and the need for opioids after knee replacement surgery. The researchers aim to determine if adding genicular and anterior femoral cutaneous nerve blocks (a type of pain management technique) can lower pain scores and speed up recovery immediately after surgery. Participants will receive either these nerve blocks with standard care or just standard care to compare results. It suits individuals having one knee replaced, who do not have chronic pain, and are not regularly on strong painkillers. As a Phase 4 trial, this research involves an FDA-approved treatment and seeks to understand its benefits for more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are currently taking anticonvulsants, you cannot participate in the trial.

What is the safety track record for the genicular and anterior femoral cutaneous nerve blocks?

Research has shown that genicular nerve blocks and anterior femoral cutaneous nerve blocks are generally safe for patients. Studies have found that these nerve blocks can effectively relieve pain after knee replacement surgery without causing muscle weakness, meaning they do not affect movement.

One study examined a similar procedure called genicular nerve radiofrequency ablation and found it safe for reducing knee pain. Although radiofrequency ablation differs slightly, the safety results provide some confidence in using nerve blocks for pain relief.

Since the trial is in a late phase, a substantial amount of safety evidence exists. Earlier trials have likely shown these nerve blocks to be well-tolerated. While no treatment is without risks, existing data suggests that serious side effects are uncommon with these nerve blocks. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about nerve blocks in knee replacement surgery because they could provide more targeted pain relief compared to standard pain management options. Unlike typical treatments that rely on systemic medications like opioids, these nerve blocks specifically target the genicular and anterior femoral cutaneous nerves, potentially offering better localized pain control. This targeted approach might reduce the need for opioids, minimizing side effects and improving recovery times for patients. By focusing directly on the nerves involved in knee pain, these blocks can provide a more effective and tailored pain management solution during and after surgery.

What evidence suggests that genicular and anterior femoral cutaneous nerve blocks are effective for reducing pain and opioid use after knee replacement surgery?

Research shows that certain nerve blocks can help manage pain after knee replacement surgery. In this trial, participants in the Genicular TKA group will receive a genicular nerve block and anterior femoral cutaneous nerve block, targeting specific nerves around the knee to reduce pain signals. Studies have found that patients receiving these nerve blocks experience less pain after surgery and require fewer strong painkillers, like opioids, which can have side effects. Additionally, these nerve blocks may help patients recover faster by allowing them to move sooner and feel more comfortable overall. These nerve blocks are a promising option for improving pain management after knee surgery. ^{1 2 6 7 8}

Who Is on the Research Team?

Jiabin Liu, MD, PhD

Principal Investigator

Hospital for Special Surgery, New York

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

BMI < 35

ASA I-III

I am having or had a knee replacement surgery and stayed less than 24 hours.

Exclusion Criteria

Psychiatric or cognitive disorder that prohibits patient from following study protocol

I cannot have spinal or epidural anesthesia.

I have a long-term pain condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo total knee arthroplasty with either standard care or additional genicular and anterior femoral cutaneous nerve blocks

1 day

1 visit (in-person)

Immediate Post-operative Care

Participants are monitored in the post-anesthesia care unit (PACU) for pain management and readiness for discharge

24 hours

Continuous monitoring

Follow-up

Participants are monitored for pain levels and opioid consumption post-surgery

7 days

Daily assessments

What Are the Treatments Tested in This Trial?

Interventions

• Genicular and Anterior Femoral Cutaneous Nerve Blocks

Trial Overview 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.

How Is the Trial Designed?

Group I: Group 2 Genicular TKA Experimental Treatment 4 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 TKA Active Control 1 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).

Genicular and Anterior Femoral Cutaneous Nerve Blocks is already approved in United States, European Union for the following indications:

Approved in United States as Genicular Nerve Block for:

• Acute postoperative pain in total knee arthroplasty

Approved in European Union as Genicular Nerve Block for:

• Acute postoperative pain in total knee arthroplasty

Who Is Running the Clinical Trial?

Hospital for Special Surgery, New York

Lead Sponsor

Trials

257

Recruited

61,800+

Published Research Related to This Trial

In a study involving 90 patients undergoing anterior cruciate ligament reconstruction, a continuous femoral nerve block with ropivacaine did not show a significant advantage over an intra-articular injection of bupivacaine/morphine in terms of pain control in the first 24 hours post-surgery.

Both pain management techniques resulted in similar pain ratings and total narcotic use, indicating that either method can be effectively used for postoperative pain relief after this type of surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous femoral nerve block versus intra-articular injection for pain control after anterior cruciate ligament reconstruction. Woods, GW., O'Connor, DP., Calder, CT.[2022]

The study established precise anatomical landmarks for fluoroscopy-guided genicular nerve blockade (GNB) in a cadaveric model, achieving 100% accuracy for four out of five targeted genicular nerves.

This improved technique could enhance the effectiveness of GNB in treating chronic knee pain by ensuring more accurate targeting of the genicular nerves.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accuracy of fluoroscopic-guided genicular nerve blockade: a need for revisiting anatomical landmarks. Fonkoue, L., Behets, CW., Steyaert, A., et al.[2021]

A combined femoral and anterior sciatic nerve block provides effective postoperative pain control for patients undergoing knee arthroplasty, with a mean pain-free duration of 42.1 hours reported.

This technique allows for early rehabilitation, as 62.8% of patients could bend their knee to 90 degrees by the third day, and it was performed without complications, leading to high patient satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Postoperative analgesia in knee arthroplasty using an anterior sciatic nerve block and a femoral nerve block]. del Fresno Cañiaveras, J., Campos, A., Galiana, M., et al.[2019]

Ultrasound-guided genicular nerve blocks (GNBs) provide effective pain relief for acute knee pain, as demonstrated in a case where a 68-year-old woman experienced a significant reduction in pain from 8/10 to 0/10 at rest after the procedure.

GNBs are a safe, motor-sparing analgesic option that can be performed in the emergency department, allowing patients to avoid opioid use during their visit and upon discharge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel Use of 3-Point Genicular Nerve Block for Acute Knee Pain in the Emergency Department. Sobel, J., Oswald, J.[2021]

Ultrasound-guided genicular nerve block effectively controls pain in patients with knee osteoarthritis (OA) by targeting the geniculate nerve, which provides sensory innervation to the knee joint.

This procedure allows for pain relief without significant motor impairment, making it a safer option compared to traditional nerve blocks that affect motor function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Procedural Approach to Ultrasound-Guided Geniculate Nerve Blockade for Knee Pain in Patients with OA. Henry, S., Best, TM., Jose, J., et al.[2023]

This study demonstrated that ultrasound-guided genicular nerve block can be accurately performed using specific anatomical landmarks, with successful dye placement in all tested specimens, indicating high precision in targeting the medial genicular nerves.

The anatomical locations for the superior medial genicular nerve (SMGN) and inferior medial genicular nerve (IMGN) were clearly defined, providing a reliable framework for clinicians to improve the efficacy of chronic knee pain treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accuracy of Ultrasound-Guided Genicular Nerve Block: A Cadaveric Study. Yasar, E., Kesikburun, S., Kılıç, C., et al.[2022]

In a study of 26 patients with knee osteoarthritis in Cameroon, genicular nerve blockade significantly reduced pain and perceived difficulty, indicating its efficacy as a treatment option.

The procedure also improved gait and stair climbing performance, with notable increases in cadence and joint motion, demonstrating immediate functional benefits for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lower limb kinematics improvement after genicular nerve blockade in patients with knee osteoarthritis: a milestone study using inertial sensors. Lebleu, J., Fonkoue, L., Bandolo, E., et al.[2022]

Administering a femoral nerve block with Bupivacaine 0.5% before knee joint reconstruction surgery significantly reduced the need for opiate pain relief by 80% in the recovery room and 40% in the first 24 hours post-surgery.

The study highlights that performing a femoral nerve block is an effective and quick technique that can greatly enhance postoperative pain management for patients undergoing anterior cruciate ligament reconstruction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Femoral nerve block in knee joint surgery. Ringrose, NH., Cross, MJ.[2017]

In a study of 107 patients undergoing total knee arthroplasty, those who received multiple nerve blocks (femoral, sciatic, obturator, and lateral femoral cutaneous) experienced significantly better pain relief and lower morphine consumption compared to those who only received a femoral nerve block or no nerve block at all.

The results indicate that a single femoral nerve block alone provides inadequate pain management immediately after surgery, highlighting the importance of using multiple nerve blocks for optimal postoperative analgesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Femoral versus Multiple Nerve Blocks for Analgesia after Total Knee Arthroplasty. Stav, A., Reytman, L., Sevi, R., et al.[2020]

In a randomized controlled trial involving 40 patients undergoing total knee arthroplasty, genicular nerve blockade significantly reduced opioid consumption at 24 hours post-surgery (23±20 mg vs 58±35 mg for the placebo group, p<0.001).

The genicular nerve blockade also led to lower pain scores at 6 hours after surgery (2.6±1.9 vs 4.3±2.2, p=0.012), indicating its efficacy in managing acute pain after knee surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound-guided genicular nerve blocks following total knee arthroplasty: a randomized, double-blind, placebo-controlled trial. Rambhia, M., Chen, A., Kumar, AH., et al.[2022]

In a study of 140 patients undergoing total knee arthroplasty, intraoperative landmark-based genicular nerve blocks (GNB) provided similar resting pain relief compared to periarticular infiltration (PAI), with both groups reporting median pain scores of 0 at 12 hours post-surgery.

However, GNB did not achieve non-inferiority for pain during movement, as patients in the GNB group experienced higher pain scores and required more intravenous morphine for pain management compared to the PAI group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraoperative landmark-based genicular nerve block versus periarticular infiltration for postoperative analgesia in total knee arthroplasty: a randomized non-inferiority trial. Kertkiatkachorn, W., Ngarmukos, S., Tanavalee, A., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05980546

Genicular and Anterior Femoral Cutaneous Nerve Blocks ... The goal of this randomized controlled trial is to examine if there is a relationship between the addition of the genicular nerve block and anterior femoral ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11564395/

Different peripheral nerve blocks for patients undergoing ... To comprehensively compare the effect of different peripheral nerve blocks for patients undergoing total knee arthroplasty (TKA).

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05980546/genicular-and-anterior-femoral-cutaneous-nerve-blocks-for-total-knee-arthroplasty

Genicular and Anterior Femoral Cutaneous Nerve Blocks ... The goal of this randomized controlled trial is to examine if there is a relationship between the addition of the genicular nerve block and ...

4. associationofanaesthetists-publications.onlinelibrary.wiley.com associationofanaesthetists-publications.onlinelibrary.wiley.com/doi/10.1111/anae.15909

Ultrasound‐guided genicular nerves block vs. local infiltration ... Genicular nerves block is a promising technique to treat acute postoperative pain in total knee arthroplasty.

5. withpower.com withpower.com/trial/phase-4-total-knee-replacement-surgery-5-2023-053ca

Nerve Blocks for Knee Replacement Surgery Trial Overview The study tests if adding genicular and anterior femoral cutaneous nerve blocks to standard care reduces pain and opioid use after knee surgery.

6. sciencedirect.com sciencedirect.com/science/article/pii/S2772594423000791

The safety and efficacy of genicular nerve radiofrequency ... Genicular nerve radiofrequency ablation (RFA) is an effective procedure to alleviate knee pain. This procedure has been proven to be safe, except in the ...

7. journaloei.scholasticahq.com journaloei.scholasticahq.com/article/136350-enhanced-pain-management-in-total-knee-arthroplasty-a-retrospective-analysis-on-intraoperative-cryo-neurolysis

Enhanced Pain Management in Total Knee Arthroplasty The procedure targeted the superior medial genicular nerve (SMG), inferior medial genicular nerve (IMG), superior lateral genicular nerve (SLG), ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10691610/

Comparison of ultrasound-guided genicular nerve block ... Periarticular infiltration and genicular nerve block yield effective postoperative analgesia and functional outcomes after TKA without motor affection.