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临床试验/NCT03733509
NCT03733509已完成不适用

Intraoperative Direct Adductor Canal Nerve Block Versus Post Operative Ultrasound Guided Adductor Canal Nerve Block in Total Knee Arthroplasty: a Double-blind Randomized Trial

Pontificia Universidad Catolica de Chile2 个研究点 分布在 1 个国家目标入组 121 人开始时间: 2018年11月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
121
试验地点
2
主要终点
24 hour opioid consumption

研究概览

简要总结

This study compares analgesic effect between two techniques of adductor canal nerve block after total knee arthroplasty. The first group of the patients will receive intraoperative adductor canal nerve block; and the other group post operative ultrasound guided adductor canal nerve block. Investigators will measure postoperative opioid consumption, pain management and rehabilitation goals.

详细描述

Total knee arthroplasty (TKA) is a successful alternative to treat late stage knee osteoarthritis (OA). Pain management has been one of the main focuses of postoperative care. Most surgeons prefer a comprehensive multimodal approach including preoperative pharmacological treatment, intraoperative infiltration with complex drug mixes and postoperative peripheral nerve block.

The most common postoperative nerve block alternative is the proximal femoral nerve block (FNB) which has shown improvements on postoperative pain measured by reduced opioid consumption and decreased pain at rest. Its main detractors argue that the motor nerve block effect is deleterious to early ambulation and have promoted adductor canal nerve blocks (ACB). Described by Lund et al in 2011, ACB block main femoral pain sensory contributors to the knee (articular branches of obturator nerve, vastus medialis branch and saphenous nerve) but is more distal to most motor branches to the quadriceps allowing near to normal quadriceps strength.

Standard ACB block is performed under ultrasound guidance after surgery completion, still in the operating room (OR). Recent literature has shown the anatomic feasibility of intraoperative ACB via blunt suprapatellar dissection in standard medial parapatellar TKA approaches. The study seeks to determine the effectiveness of standard ultrasound guidance ACB compared with intraoperative ACB.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

Total blind (patient, physicians, outcome assessors and statistician) Closed envelope by independent randomizer is given to physician assistant. The assistant prepares randomly allocated placebo or local anesthetic. Group is coded so that statistician is also blind

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Primary total knee arthroplasty
  • Unilateral
  • American Society of Anesthesiologists (ASA) score I, II or III
  • Accepts spinal anesthesia

排除标准

  • General anesthesia
  • Chronic kidney disease
  • Drug or alcohol abuse
  • Chronic opioid use
  • Allergic to bupivacaine or similar

结局指标

主要结局

24 hour opioid consumption

时间窗: First 24 hours after surgery

Opioid consumption by patient controlled analgesia (PCA) and any other oral or IV analgesics

次要结局

  • 24 patient reported pain(First 24 hours after surgery)
  • Time up and go Test(24 hours after surgery)
  • Range of motion(24 hours after surgery)
  • Time to Discharge(7 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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