MedPath

Genicular Nerve Blocks for Anterior Cruciate Ligament Knee Surgery

Phase 4
Completed
Conditions
ACL
Anterior Cruciate Ligament Injuries
Interventions
Registration Number
NCT05720949
Lead Sponsor
Hospital for Special Surgery, New York
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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
192
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Group 2 - InterventionGenicular Nerve Block with bupivacaine and preservative free dexamethasonePatients 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.
Primary Outcome Measures
NameTimeMethod
Mean Opioid Consumption at 24 hoursPost-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
NameTimeMethod
Opioid consumptionPACU(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.

Numeric Rating Scale (NRS) Pain ScoresPACU (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.

Cumulative opioid pills consumptionsum 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.

Brief Pain InventoryPre-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.

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

Although recorded at different timepoints, the average pain score will be calculated and reported.

Patient satisfaction with pain treatmentFrom 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.

Duration of analgesic block24 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.

Success of adductor canal blockThe 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

readiness for PACU dischargeFrom 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.

Length of PACU stayFrom 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.

Adverse eventsPost-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.

Trial Locations

Locations (1)

HSS Sports Medicine Institute West Side

🇺🇸

New York, New York, United States

© Copyright 2025. All Rights Reserved by MedPath