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临床试验/NCT02794974
NCT02794974已完成不适用

Ultrasound-guided Intermediate Cervical Plexus Block for Carotid Endarterectomies

Helios Research Center2 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2016年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
29
试验地点
2
主要终点
Local Anesthetic Supplementation (Volume)

研究概览

简要总结

The investigators test with the present study design, whether an ultrasound-guided blockade of the cervical plexus in combination with an additional application of local anesthetic to the superficial cervical ansa (facial nerve: cervical branch) leads to an improved quality of anesthesia.

详细描述

The innervation of the neck area is complex and includes cranial nerve (innervation of the vessel wall (IX,X) and of the neck muscles (VII,XI)), as well as the cervical plexus and brachial plexus. This is a major cause of insufficient anesthesia quality during carotid endarterectomies.

The investigators test with the present prospective study design, whether an ultrasound-guided blockade of the cervical plexus in combination with an additional application of local anesthetic to the superficial cervical ansa (facial nerve: cervical branch) leads to an improved quality of anesthesia.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

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

  • internal carotid stenosis: open surgical revascularization
  • age over 18 years
  • written informed consent

排除标准

  • allergy (local anesthetics)
  • pregnancy
  • participation in other studies
  • drug addiction
  • non-cooperative patients

研究组 & 干预措施

with perivascular block

Experimental
  1. ultrasound-guided intermediate cervical plexus block (20ml ropivacaine 0.75%) 2. facial nerve block (cervical branch) (5ml prilocaine 1%) 3. perivascular block (5ml prilocaine 1%)

干预措施: cervical plexus block (Other)

with perivascular block

Experimental
  1. ultrasound-guided intermediate cervical plexus block (20ml ropivacaine 0.75%) 2. facial nerve block (cervical branch) (5ml prilocaine 1%) 3. perivascular block (5ml prilocaine 1%)

干预措施: facial nerve block (Other)

with perivascular block

Experimental
  1. ultrasound-guided intermediate cervical plexus block (20ml ropivacaine 0.75%) 2. facial nerve block (cervical branch) (5ml prilocaine 1%) 3. perivascular block (5ml prilocaine 1%)

干预措施: perivascular block (Other)

without perivascular block

Experimental
  1. ultrasound-guided intermediate cervical plexus block (20ml ropivacaine 0.75%) 2. facial nerve block (cervical branch) (5ml prilocaine 1%)

干预措施: cervical plexus block (Other)

without perivascular block

Experimental
  1. ultrasound-guided intermediate cervical plexus block (20ml ropivacaine 0.75%) 2. facial nerve block (cervical branch) (5ml prilocaine 1%)

干预措施: facial nerve block (Other)

结局指标

主要结局

Local Anesthetic Supplementation (Volume)

时间窗: intraoperatively

volume of prilocaine 1% supplemented by the surgeon (ml)

Local Anesthetic Supplementation (Frequency)

时间窗: intraoperatively

number of participants who need supplementation of prilocaine 1% by the surgeon (%)

次要结局

  • Cough(intraoperatively)
  • Dysphagia(intraoperatively)
  • Hoarseness(intraoperatively)

研究者

发起方
Helios Research Center
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr.med.Ronald Seidel

MD

Helios Research Center

研究点 (2)

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