Genicular Nerve Blocks for Anterior Cruciate Ligament Knee Surgery

NCT05720949 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 2022-1962
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this randomized controlled trial is to assess a new analgesia regimen that includes the addition of genicular never blocks to our current standard regimen of peripheral nerve blocks, which includes an adductor canal block (ACB) and interspace between the popliteal artery and capsule of the posterior knee block (IPACK). The main questions it aims to answer are:

1. 1.Does addition of genicular nerve blocks to standard peripheral block regimen significantly reduce the mean opioid consumption by 33% in the first 24 hours?
2. 2.Does genicular nerve blocks reduce NRS pain scores?
3. 3.Does genicular nerve blocks facilitate earlier discharge?
4. 4.Does genicular nerve blocks last longer than 24 hours?
5. 5.Does genicular nerve blocks improve pain management?

Conditions

ACL; Anterior Cruciate Ligament Injuries

Keywords

ACL; Genicular nerve block; Anterior Cruciate Ligament Injuries; Opioid Consumption

Outcome Measures

Primary Outcomes (1)

• Mean Opioid Consumption at 24 Hours

  Intravenous and Oral opioid consumption at 24 hours after recovery room entry will be recorded. The average consumption will be reported in morphine milligram equivalents.

  Post-operative care unit (PACU) arrival time to 24 hours

Secondary Outcomes (10)

• Opioid Consumption

  PACU(PACU arrival time to removal from board), 48,72,96,168 hours after time zero (PACU arrival time)

• Numeric Rating Scale (NRS) Pain Scores

  PACU (60 minutes after PACU arrival time), 24,48,72,96,168 hours after time zero (PACU arrival time)

• Cumulative Opioid Consumption

  sum of opioid used from 0-24 hours, 0-48 hours, and 0-72 hours, 0-96 hours post-operatively

• Brief Pain Inventory

  Pre-operatively, 24 hours, 48 hours, 72 hours, 96 hours, 168 hours post-operative

• Patient Satisfaction With Pain Treatment

  From the time patient arrived in the post-operative care unit (PACU), at 24 hours, and at 48 hours post-operative

Study Arms (2)

Group 1 - Control

NO 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.

Group 2 - Intervention

EXPERIMENTAL

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.

Drug: Genicular Nerve Block with bupivacaine and preservative free dexamethasone

Interventions

Genicular Nerve Block with bupivacaine and preservative free dexamethasone DRUG

A genicular nerve block is a peripheral nerve block that temporarily anesthetizes the sensory terminal branches innervating the knee joint by injecting local anesthesia. This results in anesthesia of the anterior compartment of the knee. The genicular nerve block consists of 20cc of 0.25% bupivacaine with 2mg of preservative free dexamethasone and will be applied to the superomedial genicular nerve, superolateral genicular nerve, inferomedial genicular nerve, and nerve to vastus intermedius. Bupivacaine - Drug class: Sodium channel blocker Dexamethasone - Drug class: Glucocorticoid

Also known as: Exparel, Ozurdex

Group 2 - Intervention

Eligibility Criteria

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

You may qualify if:

• Age 18 - 80
• English speaking
• American Society of Anesthesiologists (ASA) I - III
• BMI \< 35
• Scheduled for ambulatory arthroscopic unilateral anterior cruciate ligament repair surgery with bone tendon bone autograft

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
• Psychiatric or cognitive disorder that prohibit patient from following study protocol
• Allergy to local anesthetic or study medications
• Multi-ligament surgery
• History of substance abuse
• Infection at the site of injection
• diagnoses of Type I or Type II diabetes

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead

Study Sites (1)

HSS Sports Medicine Institute West Side

New York, New York, 10019, United States

Location

Related Publications (7)

• 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 BACKGROUND

• 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 BACKGROUND

• Caldwell GL Jr, Selepec MA. Reduced Opioid Use After Surgeon-Administered Genicular Nerve Block for Anterior Cruciate Ligament Reconstruction in Adults and Adolescents. HSS J. 2019 Feb;15(1):42-50. doi: 10.1007/s11420-018-09665-9. Epub 2019 Jan 28.

  PMID: 30863232 BACKGROUND

• Gruskay JA, Pearce SS, Ruttum D, Conrad ES 3rd, Hackett TR. Surgeon-Administered Anterolateral Geniculate Nerve Block as an Adjunct to Regional Anesthetic for Pain Management Following Anterior Cruciate Ligament Reconstruction. Arthrosc Tech. 2022 Jan 20;11(1):e1-e6. doi: 10.1016/j.eats.2021.08.034. eCollection 2022 Jan.

  PMID: 35127422 BACKGROUND

• Kim DH, Lin Y, Goytizolo EA, Kahn RL, Maalouf DB, Manohar A, Patt ML, Goon AK, Lee YY, Ma Y, Yadeau JT. Adductor canal block versus femoral nerve block for total knee arthroplasty: a prospective, randomized, controlled trial. Anesthesiology. 2014 Mar;120(3):540-50. doi: 10.1097/ALN.0000000000000119.

  PMID: 24401769 BACKGROUND

• Kim DH, Beathe JC, Lin Y, YaDeau JT, Maalouf DB, Goytizolo E, Garnett C, Ranawat AS, Su EP, Mayman DJ, Memtsoudis SG. Addition of Infiltration Between the Popliteal Artery and the Capsule of the Posterior Knee and Adductor Canal Block to Periarticular Injection Enhances Postoperative Pain Control in Total Knee Arthroplasty: A Randomized Controlled Trial. Anesth Analg. 2019 Aug;129(2):526-535. doi: 10.1213/ANE.0000000000003794.

  PMID: 30234517 BACKGROUND

• Kim DH, Lin Y, Beathe JC, Liu J, Oxendine JA, Haskins SC, Ho MC, Wetmore DS, Allen AA, Wilson L, Garnett C, Memtsoudis SG. Superior Trunk Block: A Phrenic-sparing Alternative to the Interscalene Block: A Randomized Controlled Trial. Anesthesiology. 2019 Sep;131(3):521-533. doi: 10.1097/ALN.0000000000002841.

  PMID: 31283740 BACKGROUND

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Interventions

Bupivacaine; Calcium Dobesilate

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

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

Results Point of Contact

• Title: Maya Tailor
• Organization: Hospital for Special Surgery

tailorm@hss.edu

646-714-6828

Study Officials

• Jashvant Poeran, MD/PhD

  Hospital for Special Surgery, Department of Anesthesiology

  STUDY DIRECTOR

• David H Kim, MD

  Hospital for Special Surgery, Department of Anesthesiology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The patient, research assistants, and biostatisticians are blinded to whether the patient was randomized to the control or intervention group.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double blind randomized control trail

Study Record Dates

• First Submitted: January 18, 2023
• First Posted: February 9, 2023
• Study Start: January 12, 2023
• Primary Completion: November 26, 2024
• Study Completion: December 2, 2024
• Last Updated: January 26, 2026
• Results First Posted: January 26, 2026

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)