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临床试验/NCT02336958
NCT02336958已完成不适用

Ultrasound Guided Intermediate Cervical Plexus Block -Randomized Evaluation Concerning the Significance of Additional Perivascular Local Anesthetic Infiltration

Helios Research Center0 个研究点目标入组 40 人开始时间: 2013年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
主要终点
Amount (ml) of Local Anesthetic Supplemented by Surgeon

研究概览

简要总结

For ultrasound guided intermediate cervical plexus block this randomized comparison is testing the hypothesis, that an additional perivascular infiltration is associated with increased block quality.

详细描述

The innervation of the neck is complex and involves the cervical and the brachial plexus as well as cranial nerves. So is the wall of the carotid arteries innervated by vagal and glossopharyngeal nerve as well as the sympathetic trunk. When carotid surgery was performed under regional anesthesia, so additional infiltration of local anesthetic by the surgeon was common, particularly during preparation of the carotid arteries.

Introduction of ultrasound guidance made it possible to guide the needle directly to the vascular wall. But this procedure is considered very demanding, because of guiding the needle in an anatomical region with artifacts (because of calcification), sudden movements (e.g. because of swallowing) and compromised coagulation (antithrombotic medication). On the other side there are no clinical data proving the benefit of an additional perivascular infiltration with local anesthetic. Therefore, this investigation is testing the hypothesis, that an additional perivascular infiltration is associated with increased block quality.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

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

  • carotid surgery (symptomatic and asymptomatic carotid stenosis)
  • adult patients (18 years or older)
  • ASA-risk-groups I-IV
  • informed consent

排除标准

  • drug allergy: local anesthetics
  • pregnancy, lactation period
  • participation in other studies
  • addiction to drugs or alcohol
  • non-cooperative patients
  • no approval to regional anesthesia

研究组 & 干预措施

ropivacaine

Active Comparator

Ultrasound guided intermediate cervical plexus block: 20ml ropivacaine 0.75%. Ultrasound guided perivascular/pericarotidal infiltration: 5ml ropivacaine 0.75%.

干预措施: intermediate cervical plexus block ropivacaine (Drug)

ropivacaine

Active Comparator

Ultrasound guided intermediate cervical plexus block: 20ml ropivacaine 0.75%. Ultrasound guided perivascular/pericarotidal infiltration: 5ml ropivacaine 0.75%.

干预措施: pericarotidal infiltration (active comparator) ropivacaine (Drug)

ropivacaine

Active Comparator

Ultrasound guided intermediate cervical plexus block: 20ml ropivacaine 0.75%. Ultrasound guided perivascular/pericarotidal infiltration: 5ml ropivacaine 0.75%.

干预措施: jugular infiltration prilocaine (Drug)

saline

Placebo Comparator

Ultrasound guided intermediate cervical plexus block: 20ml ropivacaine 0.75%. Ultrasound guided perivascular/pericarotidal infiltration: 5ml saline 0.9%.

干预措施: intermediate cervical plexus block ropivacaine (Drug)

saline

Placebo Comparator

Ultrasound guided intermediate cervical plexus block: 20ml ropivacaine 0.75%. Ultrasound guided perivascular/pericarotidal infiltration: 5ml saline 0.9%.

干预措施: jugular infiltration prilocaine (Drug)

saline

Placebo Comparator

Ultrasound guided intermediate cervical plexus block: 20ml ropivacaine 0.75%. Ultrasound guided perivascular/pericarotidal infiltration: 5ml saline 0.9%.

干预措施: pericarotidal infiltration (placebo comparator) saline (Drug)

结局指标

主要结局

Amount (ml) of Local Anesthetic Supplemented by Surgeon

时间窗: during the intraoperative period

Number of Patients With Required Supplementation of Local Anesthetic by Surgeon

时间窗: during the intraoperative period

次要结局

未报告次要终点

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

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