- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05720949
Genicular Nerve Blocks for Anterior Cruciate Ligament Knee Surgery
Genicular Nerve Blocks for Arthroscopic Anterior Cruciate Knee Surgery: a Randomized Controlled Trial
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:
- Does addition of genicular nerve blocks to standard peripheral block regimen significantly reduce the mean opioid consumption by 33% in the first 24 hours?
- Does genicular nerve blocks reduce NRS pain scores?
- Does genicular nerve blocks facilitate earlier discharge?
- Does genicular nerve blocks last longer than 24 hours?
- 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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10019
- HSS Sports Medicine Institute West Side
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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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.
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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. |
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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Mean Opioid Consumption at 24 Hours
Time Frame: Post-operative care unit (PACU) arrival time to 24 hours
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Opioid Consumption
Time Frame: PACU(PACU arrival time to removal from board), 48,72,96,168 hours after time zero (PACU arrival time)
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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. |
PACU(PACU arrival time to removal from board), 48,72,96,168 hours after time zero (PACU arrival time)
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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)
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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.
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PACU (60 minutes after PACU arrival time), 24,48,72,96,168 hours after time zero (PACU arrival time)
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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
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Total opioid consumption will be recorded up to 96 hours after surgery.
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sum of opioid used from 0-24 hours, 0-48 hours, and 0-72 hours, 0-96 hours post-operatively
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Brief Pain Inventory
Time Frame: Pre-operatively, 24 hours, 48 hours, 72 hours, 96 hours, 168 hours post-operative
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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". |
Pre-operatively, 24 hours, 48 hours, 72 hours, 96 hours, 168 hours post-operative
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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
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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. |
From the time patient arrived in the post-operative care unit (PACU), at 24 hours, and at 48 hours post-operative
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Duration of Analgesic Block
Time Frame: 24 hours and 48 hours post-operative
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To assess when the patient believe the analgesic block wore off and they regain sensation in their leg.
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24 hours and 48 hours post-operative
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Success of Adductor Canal Block
Time Frame: Post-operative care unit (PACU)
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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.
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Post-operative care unit (PACU)
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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.
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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. |
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.
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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.
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The duration from PACU arrival time to patient removed from board time. The time (in minutes) will be calculated and reported. |
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.
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Adverse Events
Time Frame: Post-operative care unit (PACU) arrival time up to 72 hours after the surgery
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Incidence of neuropraxia (neurological symptoms over 3 days), local anesthetic systemic toxicity (LAST), and infection. The number of adverse events will be reported. |
Post-operative care unit (PACU) arrival time up to 72 hours after the surgery
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Collaborators and Investigators
Investigators
- Principal Investigator: David H Kim, MD, Hospital for Special Surgery, Department of Anesthesiology
- Study Director: Jashvant Poeran, MD/PhD, Hospital for Special Surgery, Department of Anesthesiology
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Wounds and Injuries
- Leg Injuries
- Knee Injuries
- Anterior Cruciate Ligament Injuries
- Sulfur Compounds
- Organic Chemicals
- Hydrocarbons
- Hydrocarbons, Cyclic
- Hydrocarbons, Aromatic
- Anilides
- Amides
- Aniline Compounds
- Amines
- Benzene Derivatives
- Sulfonic Acids
- Sulfur Acids
- Benzenesulfonates
- Arylsulfonates
- Arylsulfonic Acids
- Bupivacaine
- Calcium Dobesilate
Other Study ID Numbers
- 2022-1962
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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