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临床试验/NCT01923623
NCT01923623撤回4 期

The Effect of Combined Popliteal and Saphenous Block in Addition to General Anesthesia in Surgical Fixation of Ankle Fractures: a Prospective Randomized Study

Herlev Hospital0 个研究点开始时间: 2013年7月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
撤回
主要终点
Use of Morphine

研究概览

简要总结

This clinical, randomized, and controlled study will provide valuable scientific evidence regarding the effect of adding peripheral nerve blockades to general anaesthesia during ankle surgery. In particular, the investigators want to determine if the need for postoperative opioids will be reduced and whether this will lead to shorter admission to recovery room and fewer instances of side effects such as postoperative nausea and vomiting. In addition, the investigators will determine whether the functional outcome is improved i.e. faster and more successful rehabilitation. This would have profound benefits not only to the individual patient but also to society by reducing expenses during admission, the cost of sick leave etc.

研究设计

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

入排标准

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

入选标准

  • Age >18 years
  • Patients in need of anaesthesia for operative fixation of ankle fractures.
  • American Society of Anesthesiologists (ASA) score 1-
  • BMI > 18 og <
  • Oral and written consent

排除标准

  • Weight < 50kg
  • Allergy towards drugs used in the study
  • Patients for re-operation
  • Other fracture at the same time
  • Pregnancy
  • Daily use of opioids within two weeks before operation
  • Infection near the application site
  • Patients in need of dialysis
  • Patients with neuropathy in lower extremities

研究组 & 干预措施

Block

Experimental

Popliteal and saphenous Block with Ropivacaine

干预措施: Ropivacaine block (Drug)

NaCl

Placebo Comparator

干预措施: Ropivacaine block (Drug)

结局指标

主要结局

Use of Morphine

时间窗: 24 hours

次要结局

  • Functional rehabilitation outcome(10-14 weeks)

研究者

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

Heidi Kruse

Pregraduat research assistent

Herlev Hospital

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