Nerve Blocks for Knee Replacement Surgery

Recruiting in Palo Alto (17 mi)

Overseen by Jiabin Liu, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: Hospital for Special Surgery, New York

Must not be taking: Anticonvulsants

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

No Placebo Group

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Genicular and Anterior Femoral Cutaneous Nerve Blocks for knee replacement surgery?

Research shows that genicular nerve blocks can provide effective pain relief and improve function in patients with knee osteoarthritis, and they have been found to reduce opioid use after knee replacement surgery. Additionally, femoral nerve blocks have been shown to significantly reduce the need for pain medication after knee surgery. ^{1 2 3 4 5}

Is the genicular nerve block safe for humans?

Genicular nerve blocks have been used safely in various settings, such as for acute knee pain in the emergency department, where they provided effective pain relief without the need for opioids. They are considered a safe option for pain management with easily identifiable targets using ultrasound. ^{1 2 6 7 8}

How is the treatment of Genicular and Anterior Femoral Cutaneous Nerve Blocks for knee replacement surgery different from other treatments?

This treatment is unique because it targets specific nerves (genicular and anterior femoral cutaneous) to manage pain after knee replacement surgery, potentially offering a more focused approach compared to traditional methods like femoral nerve blocks or periarticular infiltration, which may involve broader nerve coverage. ^{1 3 9 10 11}

Research Team

Jiabin Liu, MD, PhD

Principal Investigator

Hospital for Special Surgery, New York

Eligibility Criteria

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 between 18 and 80 years old.

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.

Trial Timeline

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

Treatment Details

Interventions

• Genicular and Anterior Femoral Cutaneous Nerve Blocks (Procedure)

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.

Participant Groups

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).

Who Is Running the Clinical Trial?

Hospital for Special Surgery, New York

Lead Sponsor

Trials

257

Recruited

61,800+

Dr. Douglas E. Padgett

Hospital for Special Surgery, New York

Chief Medical Officer since 2023

MD from Cornell University Medical College

Dr. Bryan T. Kelly

Hospital for Special Surgery, New York

Chief Executive Officer since 2023

MD, MBA

Findings from Research

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]

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 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]

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]

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]

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]

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]

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]

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]

References

1. England 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. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Lower limb kinematics improvement after genicular nerve blockade in patients with knee osteoarthritis: a milestone study using inertial sensors. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Femoral nerve block in knee joint surgery. [2017]

4. England pubmed.ncbi.nlm.nih.gov

Ultrasound-guided genicular nerve blocks following total knee arthroplasty: a randomized, double-blind, placebo-controlled trial. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Procedural Approach to Ultrasound-Guided Geniculate Nerve Blockade for Knee Pain in Patients with OA. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Accuracy of Ultrasound-Guided Genicular Nerve Block: A Cadaveric Study. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

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

8. England pubmed.ncbi.nlm.nih.gov

Accuracy of fluoroscopic-guided genicular nerve blockade: a need for revisiting anatomical landmarks. [2021]

9. Israel pubmed.ncbi.nlm.nih.gov

Femoral versus Multiple Nerve Blocks for Analgesia after Total Knee Arthroplasty. [2020]

10. Spain pubmed.ncbi.nlm.nih.gov

[Postoperative analgesia in knee arthroplasty using an anterior sciatic nerve block and a femoral nerve block]. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Continuous femoral nerve block versus intra-articular injection for pain control after anterior cruciate ligament reconstruction. [2022]