Genicular Nerve Blocks for Anterior Cruciate Ligament Knee Surgery

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

192 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-12

Study Completion Date

2024-12-02

Brief Summary

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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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Detailed Description

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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.

Conditions

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ACL Anterior Cruciate Ligament Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double blind randomized control trail

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors

The patient, research assistants, and biostatisticians are blinded to whether the patient was randomized to the control or intervention group.

Study Groups

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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.

Group Type EXPERIMENTAL

Genicular Nerve Block with bupivacaine and preservative free dexamethasone

Intervention Type 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

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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Exparel Ozurdex

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No