Genicular and Anterior Femoral Cutaneous Nerve Blocks for Total Knee Arthroplasty

NCT05980546 | Completed Phase 4 FDA Drug

• 1 other identifier: 2023-0063
• Study Type: interventional
• Target: 244
• Locations: 1 country
• Sites: 1

Brief Summary

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 cutaneous nerve block in providing analgesia and the use of oral and intravenous medication in patients undergoing a total knee arthroplasty. The main questions it aims to answer are:

1. 1.Does incorporating genicular nerve block and anterior femoral cutaneous nerve block to our current standard of care reduce patients' total opioid consumption in the first 24 hours after total knee arthroplasty (TKA) surgery?
2. 2.Does incorporating genicular nerve block and anterior femoral cutaneous nerve block to our current standard of care reduce patients' worst numeric rating scale (NRS) pain score in the post-anesthesia care unit (PACU)?
3. 3.Does incorporating genicular nerve block and anterior femoral cutaneous nerve block to our current standard of care result in earlier discharge from the post-anesthesia care unit (PACU)?
4. 4.Does incorporating genicular nerve block and anterior femoral cutaneous nerve block to our current standard of care reduce patients' total opioid consumption in the first 7 days after total knee arthroplasty (TKA) surgery?
5. 5.Does incorporating genicular nerve block and anterior femoral cutaneous nerve block to our current standard of care reduce patients' numerical rating scale (NRS) pain (both at rest and during movement) in the first 24 and 48 hours after surgery?

Conditions

Total Knee Replacement; Genicular Nerve Block; Opioid Use

Outcome Measures

Primary Outcomes (2)

• Numerical Rating Scale (NRS) pain score

  The numeric rating scale (NRS) is a pain screening tool used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable".

  in the post-operative care unit (PACU) up to 24 hours after surgery end

• Cumulative opioid consumption

  The cumulative opioid consumption measured in oral morphine equivalent (OME).

  24 hours after surgery end

Secondary Outcomes (6)

• Numerical Rating Scale (NRS) pain score

  at post operative day 1 and post operative day 2

• Cumulative opioid consumption

  at post operative day 1, 2, & 7

• Brief Pain Inventory (short form)

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

• Participant satisfaction with pain treatment

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

• Readiness for home discharge

  from induction end (time zero) to readiness for discharge time, up to 7 days

Study Arms (2)

Group 1 Standard TKA

NO 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).

Group 2 Genicular TKA

EXPERIMENTAL

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).

Drug: Bupivacaine Injection; Drug: Dexamethasone injection; Drug: Fentanyl; Drug: Mepivacaine

Interventions

Bupivacaine Injection DRUG

The genicular nerve block and anterior femoral cutaneous nerve blocks consists of bupivacaine with preservative-free dexamethasone injections.

Also known as: Marcaine

Group 2 Genicular TKA

Dexamethasone injection DRUG

The genicular nerve block and anterior femoral cutaneous nerve blocks consists of bupivacaine with preservative-free dexamethasone injections.

Also known as: Ozurdex

Group 2 Genicular TKA

Fentanyl DRUG

This is a drug that is given as part of the analgesia and sedation regime. This drug is not the study intervention.

Also known as: Actiq

Group 2 Genicular TKA

Mepivacaine DRUG

This is a drug that is given as part of the analgesia and sedation regime. This drug is not the study intervention.

Also known as: Carbocaine

Group 2 Genicular TKA

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients age 18-80
• patients undergoing ambulatory unilateral total knee arthroplasty, including 23 hour stay cohort
• ASA I-III
• BMI \< 35

You may not qualify if:

• history of chronic pain syndromes
• chronic opioid use (daily morphine milligram equivalents \> 30 mg for at least 3 months)
• contraindication to peripheral nerve blocks
• contraindication to neuraxial anesthesia
• history of peripheral neuropathy or pre-existing neurological deficits
• Psychiatrics or cognitive disorder that prohibit patient from following study protocol
• allergy to local anesthetic or study medications
• multiligament surgery
• history of substance abuse
• infection at the site of injection
• chronic kidney disease
• currently taking anticonvulsants

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Related Publications (3)

• Conger A, Gililland J, Anderson L, Pelt CE, Peters C, McCormick ZL. Genicular Nerve Radiofrequency Ablation for the Treatment of Painful Knee Osteoarthritis: Current Evidence and Future Directions. Pain Med. 2021 Jul 25;22(Suppl 1):S20-S23. doi: 10.1093/pm/pnab129.

  PMID: 34308957 RESULT

• Kim DH, Choi SS, Yoon SH, Lee SH, Seo DK, Lee IG, Choi WJ, Shin JW. Ultrasound-Guided Genicular Nerve Block for Knee Osteoarthritis: A Double-Blind, Randomized Controlled Trial of Local Anesthetic Alone or in Combination with Corticosteroid. Pain Physician. 2018 Jan;21(1):41-52.

  PMID: 29357330 RESULT

• Rambhia M, Chen A, Kumar AH, Bullock WM, Bolognesi M, Gadsden J. Ultrasound-guided genicular nerve blocks following total knee arthroplasty: a randomized, double-blind, placebo-controlled trial. Reg Anesth Pain Med. 2021 Oct;46(10):862-866. doi: 10.1136/rapm-2021-102667. Epub 2021 Jul 14.

  PMID: 34261807 RESULT

MeSH Terms

Interventions

Bupivacaine; Calcium Dobesilate; Fentanyl; Mepivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jiabin Liu, MD/PhD

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Once an individual enrolls, research staff will give the anesthesiologist (a co-investigator) an opaque envelope. Inside the envelope will be an index card to let them know which group the participant is assigned to (intervention or control). Those who will be blinded as to which group the participant is assigned to are: * Participant * Research personnel (research assistants) Those who will not be blinded as to which group the participant is assigned to are: * Primary Investigator * Co-investigator * Biostatistician
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A randomized control trial of two groups, intervention vs. control.

Study Record Dates

• First Submitted: June 16, 2023
• First Posted: August 8, 2023
• Study Start: June 7, 2023
• Primary Completion: September 5, 2025
• Study Completion: September 11, 2025
• Last Updated: October 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)