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临床试验/NCT03291691
NCT03291691暂停不适用

The Use of Protective Nerve Stimulation in Different Regional Anesthetic Blocks (Interscalene, Axillary, Femoral and Sciatic Nerve Blocks)

Charite University, Berlin, Germany1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年9月20日最近更新:
适应症

试验速览

阶段
不适用
状态
暂停
入组人数
60
试验地点
1
主要终点
Effectivity

研究概览

简要总结

Peripheral nerve blocks can be conducted with ultrasound, electrical nerve stimulation or landmark technique or a combination of this techniques. Whether a regional block should be conducted with a combination of those different possibilities is highly discussed. In this study the investigators want to show the effectiveness of new standard way of combined use of ultrasound and nerve stimulation, they call protective nerve stimulation. According to ethical vote we are conducting an observational study.

详细描述

All patients will get the regional block they need for the elective surgery. Before starting the block a standard monitoring will be established. After applying the monitoring the block will be performed by an experienced anesthetist in supervision of another experienced anesthetist. The nerve stimulator is set on a fixed current of 1.0 mA and a block without motoric response on this current is tried. Ultrasound images are saved. After performing the regional anesthesia the further anesthetic procedure will be carried out and the surgery will take place. After surgery the patients will be transported to the recovery room or Postanesthesia care unit.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • written informed consent
  • age of 18 or older
  • elective surgery patients at Campus Charité Mitte with clinical benefit of regional anesthesia

排除标准

  • existing contraindication for regional nerve blocks or the use of Protective Nerve Stimulation
  • patients who undergo outpatient treatment
  • allergy against local anesthetics
  • age under 18 years
  • Lacking willingness to take part in the study
  • ASA PS score of 4 or more
  • preexisting neural damage in the effect area
  • Diabetes mellitus, alcohol use disorder
  • Participation in other prospective clinical interventional trials
  • Accommodation in an institution due to an official or judicial order

结局指标

主要结局

Effectivity

时间窗: Duration of preparation, surgery and recovery room (an average of 4 hours)

Effective motor blockade and sensitive blockade at fixed timepoints

次要结局

  • Satisfaction(Duration of preparation, surgery and recovery room (an average of 4 hours))
  • Muscle contractions(Duration of preparation, surgery and recovery room (an average of 4 hours))
  • Paresthesia(Duration of preparation, surgery and recovery room (an average of 4 hours))
  • Pain after surgery(Duration of preparation, surgery and recovery room (an average of 4 hours))
  • Impedance(Duration of preparation, surgery and recovery room (an average of 4 hours))
  • Pain while blocking(Duration of preparation, surgery and recovery room (an average of 4 hours))
  • Changes of impedance(Duration of preparation, surgery and recovery room (an average of 4 hours))

研究者

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

Jurgen Birnbaum

Principal Investigator and Consultant of the Department of Anesthesiology and Operative Intensive Care Medicine, CCM and CVK

Charite University, Berlin, Germany

研究点 (1)

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