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临床试验/NCT02071433
NCT02071433Unknown不适用

Analgesic Efficacy of Saphenous Nerve Blockade for Outpatient Knee Anterior Cruciate Ligament Surgery

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)2 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2014年3月最近更新:
适应症

试验速览

阶段
不适用
入组人数
58
试验地点
2
主要终点
Readiness to discharge from day-care center in hours according to Post-Anesthetic Discharge Scoring System (PADSS).[

研究概览

简要总结

The purpose of this study is to determine whether blockade of the saphenous nerve can provide the same degree of analgesia postoperatively for ACLS as a femoral nerve block without resulting motor blockade enhancing shortening of hospital stay en functional outcome.

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
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age 18-65 years
  • ASA status I - III
  • rupture of the anterior cruciate ligament.

排除标准

  • contraindication for regional anesthesia
  • allergy against local anesthetics
  • BMI > 35
  • pre-existing diagnosed neuropathy of the operated leg
  • ingestion of strong opioids
  • pregnancy or breastfeeding status
  • History of significant cardiovascular disease (MI, CVA, peripheral vascular disease)

结局指标

主要结局

Readiness to discharge from day-care center in hours according to Post-Anesthetic Discharge Scoring System (PADSS).[

时间窗: 1 day

次要结局

  • Sensory blockade extent(1 Day)
  • Overall Benefit of Analgesia Score (OBAS)(6 weeks)
  • SF-12 score(12 weeks)
  • KOOS-score(12 weeks)
  • IKDC-score(12 weeks)
  • Motor block(2 days)
  • Pain (VAS)(2 days)
  • Time to rescue analgesic and post operative opioid consumption(1 Day)

研究者

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

W ten Hoope

MD

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

研究点 (2)

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