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临床试验/EUCTR2015-001108-76-DK
EUCTR2015-001108-76-DK进行中(未招募)1 期

AnAnkle Trial: Peripheral nerve block vs. spinal anaesthesia for ankle fracture surgery – implications on pain profile and quality of recovery - AnAnkle Trial

Herlev Hospital, Department of Anaesthesiology I65N90 个研究点开始时间: 2015年3月19日最近更新:
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方

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 > 18 years old scheduled for internal fixation of an ankle fracture (malleolar fracture).
  • -Ability to read and understand Danish and give informed oral and written consent.
  • 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 50

排除标准

  • -Allergy towards any drug in trial protocol
  • -Bodyweight < 52 kg
  • -Contraindications for SA according to national guidelines
  • -Current gastro-intestinal bleeding
  • -Proximal fibular fracture or multitrauma/other fractures
  • -Cognitive or psychiatric dysfunction or alcohol/narcotic substance abuse causing expected inability to comply with study protocol as evaluated by anaesthesiologist/investigator
  • -No available anaesthesiologist with PNB capability at scheduled time of operation
  • -Neuropathy / neurological dysfunction in the lower extremities
  • -Habitual daily use of opioids
  • -Pregnancy (known or suspected) or breastfeeding
  • -Infection at anaesthesia injection site
  • -Nephropathy requiring dialysis
  • -Acute porphyria

研究者

发起方
Herlev Hospital, Department of Anaesthesiology I65N9

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