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Genicular Nerve Blocks for Anterior Cruciate Ligament Knee Surgery

Primary Purpose

ACL, Anterior Cruciate Ligament Injuries

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Genicular Nerve Block with bupivacaine and preservative free dexamethasone
Sponsored by
Hospital for Special Surgery, New York
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for ACL focused on measuring ACL, Genicular nerve block, Anterior Cruciate Ligament Injuries, Opioid Consumption

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • HSS Sports Medicine Institute West SideRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Group 1 - Control

Group 2 - Intervention

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Mean Opioid Consumption at 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

Opioid consumption
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 Scores
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 consumption
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 Inventory
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 treatment
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 block
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 block
numbness in the saphenous distribution will be assessed in the PACU by an anesthesiologist or research assistant
readiness for PACU discharge
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 stay
The duration from PACU arrival time to patient removed from board time. The average time (in minutes) will be calculated and reported.
Adverse events
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.

Full Information

First Posted
January 18, 2023
Last Updated
May 31, 2023
Sponsor
Hospital for Special Surgery, New York
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1. Study Identification

Unique Protocol Identification Number
NCT05720949
Brief Title
Genicular Nerve Blocks for Anterior Cruciate Ligament Knee Surgery
Official Title
Genicular Nerve Blocks for Arthroscopic Anterior Cruciate Knee Surgery: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 12, 2023 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital for Special Surgery, New York

4. Oversight

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
Data Monitoring Committee
No

5. 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: 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ACL, Anterior Cruciate Ligament Injuries
Keywords
ACL, Genicular nerve block, Anterior Cruciate Ligament Injuries, Opioid Consumption

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Double blind randomized control trail
Masking
ParticipantOutcomes Assessor
Masking Description
The patient, research assistants, and biostatisticians are blinded to whether the patient was randomized to the control or intervention group.
Allocation
Randomized
Enrollment
192 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1 - Control
Arm Type
No Intervention
Arm Description
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.
Arm Title
Group 2 - Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Genicular Nerve Block with bupivacaine and preservative free dexamethasone
Other Intervention Name(s)
Exparel, Ozurdex
Intervention Description
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
Primary Outcome Measure Information:
Title
Mean Opioid Consumption at 24 hours
Description
IV and PO opioid consumption at 24 hours after surgery will be recorded. The average consumption across all participants will be reported.
Time Frame
Post-operative care unit (PACU) arrival time to 24 hours
Secondary Outcome Measure Information:
Title
Opioid consumption
Description
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.
Time Frame
PACU(PACU arrival time to removal from board), 48,72,96,168 hours after time zero (PACU arrival time)
Title
Numeric Rating Scale (NRS) Pain Scores
Description
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.
Time Frame
PACU (60 minutes after PACU arrival time), 24,48,72,96,168 hours after time zero (PACU arrival time)
Title
Cumulative opioid pills consumption
Description
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.
Time Frame
sum of opioid used from 0-24 hours, 0-48 hours, and 0-72 hours, 0-96 hours, and 0-168 hours post-operative
Title
Brief Pain Inventory
Description
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.
Time Frame
Pre-operatively, 24 hours, 48 hours, and 96 hours post-operative
Title
Patient satisfaction with pain treatment
Description
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.
Time Frame
From the time patient arrived in the post-operative care unit (PACU), at 24 hours, and at 48 hours post-operative
Title
Duration of analgesic block
Description
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.
Time Frame
24 hours and 48 hours post-operative
Title
Success of adductor canal block
Description
numbness in the saphenous distribution will be assessed in the PACU by an anesthesiologist or research assistant
Time Frame
The time the patient arrived in the post-operative care unit (PACU) assessed up to 24 hours after surgery.
Title
readiness for PACU discharge
Description
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.
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.
Title
Length of PACU stay
Description
The duration from PACU arrival time to patient removed from board time. The average time (in minutes) will be calculated and reported.
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.
Title
Adverse events
Description
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.
Time Frame
Post-operative care unit (PACU) arrival time up to 72 hours after the surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Miriam Sheetz, BS
Phone
646-714-6685
Email
sheetzm@hss.edu
First Name & Middle Initial & Last Name or Official Title & Degree
David H Kim, MD
Phone
212-606-1206
Email
KimD@hss.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Justas Lauzadis, PhD
Organizational Affiliation
Hospital for Special Surgery, Department of Anesthesiology
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
David H Kim, MD
Organizational Affiliation
Hospital for Special Surgery, Department of Anesthesiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
HSS Sports Medicine Institute West Side
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David H Kim, MD
Phone
212-606-1206
Email
KimD@hss.edu
First Name & Middle Initial & Last Name & Degree
David H Kim, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share individual patient data with other researchers.
Citations:
PubMed Identifier
34308957
Citation
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.
Results Reference
background
PubMed Identifier
34261807
Citation
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.
Results Reference
background
PubMed Identifier
30863232
Citation
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.
Results Reference
background
PubMed Identifier
35127422
Citation
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.
Results Reference
background
PubMed Identifier
24401769
Citation
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.
Results Reference
background
PubMed Identifier
30234517
Citation
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.
Results Reference
background
PubMed Identifier
31283740
Citation
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.
Results Reference
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Genicular Nerve Blocks for Anterior Cruciate Ligament Knee Surgery

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