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临床试验/NCT02737137
NCT02737137Unknown不适用

Monitoring Combining Neurostimulation and Ultrasound Guidance During the Realization of a Peripheral Nerve Block: Value of Objective Measurement of the Pressure of Injection of the Local Anesthetic

University Hospital, Montpellier2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2016年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
120
试验地点
2
主要终点
Manual measurement

研究概览

简要总结

In clinical practice, local anesthetic injection pressure monitoring is performed manually or by a pressure transducer according to the availability of the equipment or preferences of clinicians. To date, no comparative study has measured the advantages of this measure during PNB.

The aim of this study is to evaluate injection pressure monitoring in order to reduce the risk of intraneural injection during peripheral nerve blocks

详细描述

Current recommendations for peripheral nerve block (PNB) procedure advocate combining ultrasound guidance and nerve stimulation.

Despite these different means of identification, nerves contacts and intraneural injection are frequent. Even rare, nerve damage may occur.

The nerve damage may be related to direct trauma with the needle or inadvertent intra-neural injection. High injection pressure of local anesthetic (AL) is an indicator that further characterize the location of the needle in terms of tissue density. In clinical practice, local anesthetic injection pressure monitoring is performed manually or by a pressure transducer according to the availability of the equipment or preferences of clinicians. To date, no comparative study has measured the advantages of this measure during PNB.

The aim of this study is to evaluate injection pressure monitoring in order to reduce the risk of intraneural injection.

Group 1: ultrasound-guided technique PNB "in plane" needle approach, nerve stimulator set to sentinel mode. Manual injection pressure control Group 2: ultrasound-guided PNB, "in plane" approach, Nerve stimulator set to detection mode. Electronic Injection Pressure controlled with low flow local anesthetic during procedure

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
Single (Investigator)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patient
  • Orthopedic surgery

排除标准

  • Allergy to local anesthetics
  • ASA score >III
  • Severe neuropathy
  • puncture site disease
  • parturient or breastfeeding

结局指标

主要结局

Manual measurement

时间窗: Intraoperative

Manual measurement of the pressure of injection of the local anesthetic during surgery for patients in Group 1

次要结局

  • Measured by a pressure gauge(Intraoperative)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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