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Completed

NCT Number: NCT05720949

Genicular Nerve Blocks for Anterior Cruciate Ligament Knee Surgery

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.

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Key information

Conditions

ACL Anterior Cruciate Ligament Injuries Knee Injuries Leg Injuries Wounds and Injuries

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

HSS Sports Medicine Institute West Side

New York, 10019, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • diagnoses of Type I or Type II diabetes

Treatment and study plan

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

Other names: Exparel, Ozurdex

Primary outcomes

  1. Mean Opioid Consumption at 24 Hours

    Time frame: Post-operative care unit (PACU) arrival time to 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.

Secondary outcomes

  1. Opioid Consumption

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

    Opioid consumption up to 168 hours after surgery will be recorded from the medical record and patient reported phone calls

    Opioid consumption in morphine milligram equivalents will be calculated and reported for each time point.

  2. Numeric Rating Scale (NRS) Pain Scores

    Time frame: 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.

  3. Cumulative Opioid Consumption

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

    Total opioid consumption will be recorded up to 96 hours after surgery.

  4. Brief Pain Inventory

    Time frame: Pre-operatively, 24 hours, 48 hours, 72 hours, 96 hours, 168 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 preoperatively and at 24 hours, 48 hours, 72 hours, 96 hours, and 168 hours after surgery.

    Questions are rated on a scale of 0 to 10, with 0 meaning "no pain/interference" and 10 meaning "pain as bad as you can imagine/completely interferes".

  5. Patient Satisfaction With Pain Treatment

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

    Patient satisfaction will be assessed in the post-operative care unit (PACU), 24 hours, and 48 hours after surgery.

    Patients reported satisfaction for 3 subcategories: 1) Satisfaction with Pain Management, 2) Satisfaction with Being Informed and Involved with Decision Making, 3) Satisfaction with Care from Healthcare Team. Each subcategory had a scale of 0-10, with 0 being strongly dissatisfied and 10 being strongly satisfied.

  6. Duration of Analgesic Block

    Time frame: 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.

  7. Success of Adductor Canal Block

    Time frame: Post-operative care unit (PACU)

    Numbness in the saphenous distribution will be assessed in the PACU by an anesthesiologist or research assistant. This was measured on scale of 0-2, with 0 being no sensation, 1 being partial sensation, and 2 being full sensation.

  8. Readiness for PACU Discharge

    Time frame: 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 time that it took for the patient to be discharged will be calculated and reported.

  9. Length of PACU Stay

    Time frame: 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 time (in minutes) will be calculated and reported.

  10. Adverse Events

    Time frame: 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 number of adverse events will be reported.

Sponsors and collaborators

Lead sponsor

Hospital for Special Surgery, New York

Other

Registry information

Official study title

Genicular Nerve Blocks for Arthroscopic Anterior Cruciate Knee Surgery: a Randomized Controlled Trial

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 9, 2023
Registry last updated
Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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