Genicular Nerve Blocks for Anterior Cruciate Ligament Knee Surgery

Sponsor
Hospital for Special Surgery, New York (Other)
Overall Status
Recruiting
CT.gov ID
NCT05720949
Collaborator
(none)
192
1
2
23.7
8.1

Study Details

Study Description

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. 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. Does genicular nerve blocks reduce NRS pain scores?

  3. Does genicular nerve blocks facilitate earlier discharge?

  4. Does genicular nerve blocks last longer than 24 hours?

  5. Does genicular nerve blocks improve pain management?

Eligible patients are those undergoing an anterior cruciate ligament repair at the Hospital for Special Surgery and participants will be randomized to receive the intervention (genicular nerve block) or the standard of care.

Condition or Disease Intervention/Treatment Phase
  • Drug: Genicular Nerve Block with bupivacaine and preservative free dexamethasone
Phase 4

Detailed Description

Genicular nerve blocks have been shown to provide effective analgesia for chronic osteoarthritis knee pain. There are several publications supporting its use for chronic knee pain but there is a scarcity of literature in its use in the perioperative period. Recently, it has been shown to provide effective analgesia for total knee arthroplasty. This will be a novel application for it to be used for anterior cruciate ligament surgery. There are only a couple of prospective and retrospective studies that showed promising analgesic benefits for anterior cruciate ligament repairs. There are currently no randomized controlled trials published investigating the use of genicular nerve blocks for anterior cruciate ligament surgery.

Researching novel innovative motor-sparing and opioid-sparing peripheral nerve blocks for have been the focus of research. Studies have investigated the motor sparing benefits of the adductor canal block, the effective analgesic benefits of the IPACK block, the phrenic sparing benefits of the superior trunk block, and the analgesic benefits of the pericapsular nerve group block and lateral femoral cutaneous nerve. Genicular nerve blocks would be a potential additive block that may further enhance the recovery of patients undergoing knee surgeries, including unicondylar, total knee and anterior cruciate ligament repair patients.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
192 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Double blind randomized control trailDouble blind randomized control trail
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
The patient, research assistants, and biostatisticians are blinded to whether the patient was randomized to the control or intervention group.
Primary Purpose:
Other
Official Title:
Genicular Nerve Blocks for Arthroscopic Anterior Cruciate Knee Surgery: a Randomized Controlled Trial
Actual Study Start Date :
Jan 12, 2023
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Jan 1, 2025

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Group 1 - Control

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.

Experimental: Group 2 - Intervention

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
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
Other Names:
  • Exparel
  • Ozurdex
  • Outcome Measures

    Primary Outcome Measures

    1. Mean Opioid Consumption at 24 hours [Post-operative care unit (PACU) arrival time to 24 hours]

      IV and PO opioid consumption at 24 hours after surgery will be recorded. The average consumption across all participants will be reported.

    Secondary Outcome Measures

    1. Opioid consumption [PACU(PACU arrival time to removal from board), 48,72,96,168 hours after time zero (PACU arrival time)]

      IV and PO opioid consumption up to 168 hours after surgery will be recorded from the medical record and patient reported phone calls Although recorded at different timepoints, the average opioid consumption will be calculated and reported.

    2. 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)]

      Patient scores at rest and with movement will be recorded. Scale of 0 to 10, with 0 meaning "no pain" and 10 meaning "worst pain imaginable". Lower score means less pain, higher score means greater pain. Although recorded at different timepoints, the average pain score will be calculated and reported.

    3. Cumulative opioid pills consumption [sum of opioid used from 0-24 hours, 0-48 hours, and 0-72 hours, 0-96 hours, and 0-168 hours post-operative]

      total number of opioid pills taken will be recorded up to 168 hours after surgery. Although recorded at different timepoints, the average number of opioid pills will be calculated and reported.

    4. Brief Pain Inventory [Pre-operatively, 24 hours, 48 hours, and 96 hours post-operative]

      This questionnaire will assess severity of pain, impact of pain on daily function, location of pain, medication intake, and amount of pain relief at 24 hours, 48 hours, and 96 hours after surgery. Although recorded at different timepoints, the average pain score will be calculated and reported.

    5. 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]

      patient satisfaction with study and pain treatment will be assessed in the post-operative care unit (PACU), 24 hours, and 48 hours after surgery. Although recorded at different timepoints, the average satisfaction score will be calculated and reported.

    6. Duration of analgesic block [24 hours and 48 hours post-operative]

      To assess when the patient believe the analgesic block wore off and they regain sensation in their leg. Although recorded at different timepoints, the average will be calculated and reported.

    7. Success of adductor canal block [The time the patient arrived in the post-operative care unit (PACU) assessed up to 24 hours after surgery.]

      numbness in the saphenous distribution will be assessed in the PACU by an anesthesiologist or research assistant

    8. readiness for PACU discharge [From the time the patient arrived in the post-operative care unit (PACU) arrival time to the time the patient is discharged(discharge ready time = recovery complete time) assessed up to 24 hours after surgery.]

      The duration from PACU arrival time to recovery complete time. The average time (in minutes) that it took for the patient to be discharged will be calculated and reported.

    9. Length of PACU stay [From the time the patient arrived in the post-operative care unit (PACU) arrival time to the time they leave the PACU assessed up to 24 hours after surgery.]

      The duration from PACU arrival time to patient removed from board time. The average time (in minutes) will be calculated and reported.

    10. Adverse events [Post-operative care unit (PACU) arrival time up to 72 hours after the surgery]

      Incidence of neuropraxia (neurological symptoms over 3 days), local anesthetic systemic toxicity (LAST), and infection. The average number of adverse events will be calculated and reported.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • 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

    Exclusion Criteria:
    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 HSS Sports Medicine Institute West Side New York New York United States 10019

    Sponsors and Collaborators

    • Hospital for Special Surgery, New York

    Investigators

    • Study Director: Justas Lauzadis, PhD, Hospital for Special Surgery, Department of Anesthesiology
    • Principal Investigator: David H Kim, MD, Hospital for Special Surgery, Department of Anesthesiology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    David Kim, Attending Anesthesiologist, Hospital for Special Surgery, New York
    ClinicalTrials.gov Identifier:
    NCT05720949
    Other Study ID Numbers:
    • 2022-1962
    First Posted:
    Feb 9, 2023
    Last Update Posted:
    Feb 9, 2023
    Last Verified:
    Feb 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by David Kim, Attending Anesthesiologist, Hospital for Special Surgery, New York
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 9, 2023