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临床试验/NCT05720949
NCT05720949
已完成
4 期

Genicular Nerve Blocks for Arthroscopic Anterior Cruciate Knee Surgery: a Randomized Controlled Trial

Hospital for Special Surgery, New York1 个研究点 分布在 1 个国家目标入组 192 人2023年1月12日

概览

阶段
4 期
干预措施
Genicular Nerve Block with bupivacaine and preservative free dexamethasone
疾病 / 适应症
ACL
发起方
Hospital for Special Surgery, New York
入组人数
192
试验地点
1
主要终点
Mean Opioid Consumption at 24 Hours
状态
已完成
最后更新
3个月前

概览

简要总结

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.

详细描述

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.

注册库
clinicaltrials.gov
开始日期
2023年1月12日
结束日期
2024年12月2日
最后更新
3个月前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

发起方
Hospital for Special Surgery, New York
责任方
Sponsor

入排标准

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: Genicular Nerve Block with bupivacaine and preservative free dexamethasone

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.

结局指标

主要结局

Mean Opioid Consumption at 24 Hours

时间窗: Post-operative care unit (PACU) arrival time to 24 hours

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.

次要结局

  • Duration of analgesic block(24 hours and 48 hours post-operative)
  • Length of PACU stay(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.)
  • Adverse events(Post-operative care unit (PACU) arrival time up to 72 hours after the surgery)
  • Opioid consumption(PACU(PACU arrival time to removal from board), 48,72,96,168 hours after time zero (PACU arrival time))
  • Numeric Rating Scale (NRS) Pain Scores(PACU (60 minutes after PACU arrival time), 24,48,72,96,168 hours after time zero (PACU arrival time))
  • Patient satisfaction with pain treatment(From the time patient arrived in the post-operative care unit (PACU), at 24 hours, and at 48 hours post-operative)
  • Brief Pain Inventory(Pre-operatively, 24 hours, 48 hours, 72 hours, 96 hours, 168 hours post-operative)
  • Opioid Consumption(PACU(PACU arrival time to removal from board), 48,72,96,168 hours after time zero (PACU arrival time))
  • Cumulative Opioid Consumption(sum of opioid used from 0-24 hours, 0-48 hours, and 0-72 hours, 0-96 hours post-operatively)
  • Patient Satisfaction With Pain Treatment(From the time patient arrived in the post-operative care unit (PACU), at 24 hours, and at 48 hours post-operative)
  • Duration of Analgesic Block(24 hours and 48 hours post-operative)
  • Success of Adductor Canal Block(Post-operative care unit (PACU))
  • Readiness for PACU Discharge(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.)
  • Length of PACU Stay(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.)
  • Adverse Events(Post-operative care unit (PACU) arrival time up to 72 hours after the surgery)

研究点 (1)

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