Anterior Cruciate Ligament Injuries Clinical Trial
Official title:
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: 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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | HSS Sports Medicine Institute West Side | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Hospital for Special Surgery, New York |
United States,
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
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 |
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