Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05720949
Other study ID # 2022-1962
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date January 12, 2023
Est. completion date January 2026

Study information

Verified date April 2024
Source Hospital for Special Surgery, New York
Contact Maya Tailor, BS
Phone 646-714-6828
Email tailorm@hss.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Recruiting
Enrollment 192
Est. completion date January 2026
Est. primary completion date January 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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


Related Conditions & MeSH terms

  • ACL
  • Anterior Cruciate Ligament Injuries

Intervention

Drug:
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

Locations

Country Name City State
United States HSS Sports Medicine Institute West Side New York New York

Sponsors (1)

Lead Sponsor Collaborator
Hospital for Special Surgery, New York

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Post-operative care unit (PACU) arrival time to 24 hours
Secondary 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.
PACU(PACU arrival time to removal from board), 48,72,96,168 hours after time zero (PACU arrival time)
Secondary 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.
PACU (60 minutes after PACU arrival time), 24,48,72,96,168 hours after time zero (PACU arrival time)
Secondary 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.
sum of opioid used from 0-24 hours, 0-48 hours, and 0-72 hours, 0-96 hours, and 0-168 hours post-operative
Secondary 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.
Pre-operatively, 24 hours, 48 hours, and 96 hours post-operative
Secondary 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.
From the time patient arrived in the post-operative care unit (PACU), at 24 hours, and at 48 hours post-operative
Secondary 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.
24 hours and 48 hours post-operative
Secondary Success of adductor canal block numbness in the saphenous distribution will be assessed in the PACU by an anesthesiologist or research assistant The time the patient arrived in the post-operative care unit (PACU) assessed up to 24 hours after surgery.
Secondary 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.
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.
Secondary 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.
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.
Secondary 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.
Post-operative care unit (PACU) arrival time up to 72 hours after the surgery
See also
  Status Clinical Trial Phase
Recruiting NCT04062578 - Effects Provided by a Physiotherapy Treatment Preventing Lower Extremity Injuries in Female Football Players N/A
Recruiting NCT05461326 - Quadriceps Tendon Versus Bone Patellar Tendon Bone Autograft ACL Reconstruction RCT N/A
Completed NCT05109871 - Reliability and Validity of Inline Dynamometry Study for Measuring Knee Extensor Torque N/A
Completed NCT05504018 - Clinical and Radiological Evaluation of ACL Reconstruction Results N/A
Recruiting NCT06185231 - Investigation of the Effects of Vibration Therapy on Pain, Functionality, and Proprioception After ACL Injury N/A
Recruiting NCT03968913 - Biologic Therapy to Prevent Osteoarthritis After ACL Injury Early Phase 1
Completed NCT04408690 - Feasibility of a RCT That Compares Immediate Versus Optional Delayed Surgical Repair After ACL Injury Phase 3
Recruiting NCT06222814 - Evaluation of the Results of Two Different Methods in Management of Antero-lateral Instability of the Knee N/A
Recruiting NCT05614297 - Agreement Between Rolimeter and Lachmeter in Patients With ACL Injury
Active, not recruiting NCT05184023 - The Effect of PEMF for Patients With Quadriceps Muscle Weakness After ACLR N/A
Completed NCT04906538 - Objective Results of Anterior Cruciate Ligament Reconstruction With and Without Internal Suture Augmentation Technique Phase 2/Phase 3
Completed NCT05014009 - The Influence of Neuromuscular Training on Whole-body Movement Strategies and Knee Mechanics During Change-of-direction Tasks in Sports Science Students N/A
Not yet recruiting NCT06083818 - Anterior Cruciate Ligament Injury Prevention Protocol in Female Football Players With Dynamic Knee Valgus N/A
Recruiting NCT05584020 - Arthroscopic Anterior Cruciate Ligament Repair Versus Reconstruction for Acute Anterior Cruciate Ligament Injury N/A
Completed NCT04580290 - Jewel ACL Post Market Clinical Follow Up Study
Recruiting NCT04888052 - Prolonged Preoperative Rehabilitation in ACL Rupture. N/A
Recruiting NCT06430775 - Exploring Prolonged AMR in ACL Reconstructed Patients
Not yet recruiting NCT05580133 - All-Inside Single-Bundle for Anterior Cruciate Ligament Reconstruction With Full Thickness of the Peroneus Longus Tendon Compared to the Six-strand-hamstring Autograft (ACL)
Recruiting NCT04162613 - Can Sensorimotor Function Predict Graft Rupture After ACL Reconstruction
Not yet recruiting NCT05619393 - Comparison of Kinematic Movements Between ACL Deficiency With ACL Reconstruction and Healthy People N/A