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临床试验/NCT02100579
NCT02100579已完成4 期

Ultrasound-guided Adductor Canal Block for Total Knee Replacement: a Randomized, Double-blind Placebo Controlled Trial.

Northwestern University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2014年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
40
试验地点
1
主要终点
Opioid Consumption (mg morEq)

研究概览

简要总结

Total knee arthroplasty is associated with intense early postoperative pain. Fast track recovery programs including early therapy protocols and early hospital discharge are being implemented at various hospitals. The postoperative analgesic pain regimen should enhance functional recovery in addition to providing efficient analgesia with minimal side effects. Adductor canal blockade is commonly used to provide postoperative analgesia for total knee arthroplasty (TKA) surgery. The investigators hypothesize that an ultrasound guided adductor canal block will lower narcotic consumption and improved overall satisfaction compared to ultrasound guided sham block with normal saline (placebo) for patients undergoing minimally invasive TKA surgery.

详细描述

The investigators hypothesize that an ultrasound guided adductor canal block will lower narcotic consumption and improved overall satisfaction compared to ultrasound guided sham block with normal saline (placebo) for patients undergoing minimally invasive TKA surgery.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
40 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participants 40 to 75 years old who are presenting for minimally invasive total knee arthroplasty under spinal anesthesia

排除标准

  • Patient refusal
  • American Society of Anesthesiologists physical status classification of 4 or higher
  • Pre-existing neuropathy in the femoral or sciatic distribution
  • Coagulopathy
  • Infection at the site
  • Chronic opioid use (greater than 3 months)
  • Pregnancy
  • Medical conditions limiting physical therapy participation
  • Any other contra-indication to regional anesthesia

研究组 & 干预措施

Active Group

Active Comparator

Ultrasound-guided adductor canal blockade with 10 ml of 0.25% bupivacaine

干预措施: Bupivacaine (Drug)

Control Group

Placebo Comparator

Ultrasound-guided sham block with 10 ml of preservative free normal saline

干预措施: Preservative free normal saline (Drug)

结局指标

主要结局

Opioid Consumption (mg morEq)

时间窗: 36 hours

Opioid consumption (morphine equivalents)

次要结局

  • Length of Hospitalization(0 to 192 hours)
  • Visual Analog Scale Pain Score(Pain burden at 36hr)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Antoun Nader

Professor of Anesthesiology

Northwestern University

研究点 (1)

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