Clinical trial NCT05720949: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: ACL
Anterior Cruciate Ligament Injuries
Keywords: ACL
Genicular nerve block
Anterior Cruciate Ligament Injuries
Opioid Consumption
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2023-02-09
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double blind randomized control trail
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Mean Opioid Consumption at 24 hours
timeFrame: Post-operative care unit (PACU) arrival time to 24 hours
Secondary outcomes:
measure: Opioid consumption
timeFrame: PACU(PACU arrival time to removal from board), 48,72,96,168 hours after time zero (PACU arrival time)
measure: Numeric Rating Scale (NRS) Pain Scores
timeFrame: PACU (60 minutes after PACU arrival time), 24,48,72,96,168 hours after time zero (PACU arrival time)
measure: Cumulative opioid pills consumption
timeFrame: sum of opioid used from 0-24 hours, 0-48 hours, and 0-72 hours, 0-96 hours, and 0-168 hours post-operative
measure: Brief Pain Inventory
timeFrame: Pre-operatively, 24 hours, 48 hours, and 96 hours post-operative
measure: Patient satisfaction with pain treatment
timeFrame: From the time patient arrived in the post-operative care unit (PACU), at 24 hours, and at 48 hours post-operative
measure: Duration of analgesic block
timeFrame: 24 hours and 48 hours post-operative
measure: Success of adductor canal block
timeFrame: The time the patient arrived in the post-operative care unit (PACU) assessed up to 24 hours after surgery.
measure: readiness for PACU discharge
timeFrame: 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.
measure: Length of PACU stay
timeFrame: 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.
measure: Adverse events
timeFrame: Post-operative care unit (PACU) arrival time up to 72 hours after the surgery
Other outcomes:
Locations:
city: New York
country: United States
facility: HSS Sports Medicine Institute West Side
state: New York
Study officials:
affiliation: Hospital for Special Surgery, Department of Anesthesiology
name: Jashvant Poeran, MD/PhD
role: STUDY_DIRECTOR
affiliation: Hospital for Special Surgery, Department of Anesthesiology
name: David H Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.