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临床试验/EUCTR2013-000875-33-AT
EUCTR2013-000875-33-AT进行中(未招募)不适用

Prevention of Phantom Limb Pain After Transtibial Amputation (PLATA) - Randomized, double-blind, controlled, multi-center trial comparing Optimized intravenous pain control vs Optimized intravenous pain control plus Regional anesthesia - PLATA

Academic Medical Center, University of Amsterdam0 个研究点目标入组 400 人开始时间: 2014年4月24日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
400

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • Patients undergoing elective transtibial amputation for peripheral vascular disease, age over 18 years, ASA* status II to IV.
  • *ASA American Society of Anesthesiology.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 100
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 300

排除标准

  • - contraindication to peripheral regional anesthesia
  • - confirmed allergy to local anesthetics
  • - prior amputation resulting in current phantom limb pain
  • - severe psychiatric disease
  • - pregnancy or breastfeeding status
  • - amputation for tumour surgery
  • - traumatic amputation and
  • - inability to give written and informed consent.

研究者

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