跳至主要内容
临床试验/NCT03653000
NCT03653000Unknown不适用

Assessement of a Novel Approach to Ultrasound-guided Brachial Plexus Blockade, Located Between the Infraclavicular and the Axillary Site

University of Liege2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年4月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
20
试验地点
2
主要终点
Evaluation of motor block for the median nerve at 10 minutes post injection assessed by a scale of motor function (0 = Complete paresis, 1 = Partial paresis, 2 = Normal motion)

研究概览

简要总结

Assessement of a new approach of an ultrasound guided brachial plexus blockade between the infraclavicular and axillary area.

详细描述

After an assessement of this new approach of ultrasounded-guided brachial plexus blockade in cadavers, the aim of this human study was to asssess the validity of this method in humans. The probe will be disposed on the shoulder, and the brachial plexus will be seeked below the deltoid, lateral to the major pectoralis muscle and in the vicinity of the brachial artery. At this area, an ultrasounded guided needle was inserted with an in-plane direction towards the brachial artery and local anesthetics was disposed all around the artery, without puncturing the differents nerves. Regional blockade will be evaluated by measuring onset and duation time for sensitive and motor blockade, effectiveness of this blockade, patient's confort during the procedure, ease of the procedure for practitionner, quality of ultrasound image's interpretation before and after injection.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Arm surgery performed under axillary blockade

排除标准

  • Local anesthetics allergy
  • Coagulation disorder
  • History of chronic pain
  • Drug or alcohol abuse

研究组 & 干预措施

Patients undergoing this new block

Experimental

Descriptive study about the effectiveness and the feasability of this new approach of te ultrasound guided brachial plexus blockade

干预措施: Ultrasound guided brachial plexus blockade (Procedure)

Patients undergoing this new block

Experimental

Descriptive study about the effectiveness and the feasability of this new approach of te ultrasound guided brachial plexus blockade

干预措施: local anaesthetic injection (Drug)

结局指标

主要结局

Evaluation of motor block for the median nerve at 10 minutes post injection assessed by a scale of motor function (0 = Complete paresis, 1 = Partial paresis, 2 = Normal motion)

时间窗: 10 minutes post injection

Evaluation of motor block for the median nerve

Evaluation of motor block for the radial nerve at 10 minutes post injection assessed by a scale of motor function (0 = Complete paresis, 1 = Partial paresis, 2 = Normal motion)

时间窗: 10 minutes post injection

Evaluation of motor block for the radial nerve

Evaluation of sensitive block for the median nerve at 5 minutes post injection assessed by a scale of sensitive function (0 = No sensibility, 1 = partial insensibility to cold, 2 = Normal sensation to cold)

时间窗: 5 minutes post injection

Evaluation of sensitive block for the median nerve at 5 minutes post injection

Evaluation of sensitive block for the median nerve at 10 minutes post injection assessed by a scale of sensitive function (0 = No sensibilityto cold, 1 = partial insensibility to cold, 2 = Normal sensation to cold)

时间窗: 10 minutes post injection

Evaluation of sensitive block for the median nerve at 10 minutes post injection

Evaluation of sensitive block for the median nerve at 15 minutes post injection assessed by a scale of sensitive function (0 = No sensibilityto cold, 1 = partial insensibility to cold, 2 = Normal sensation to cold)

时间窗: 15 minutes post injection

Evaluation of sensitive block for the median nerve at 15 minutes post injection

Evaluation of sensitive block for the median nerve at 20 minutes post injection assessed by a scale of sensitive function (0 = No sensibilityto cold, 1 = partial insensibility to cold, 2 = Normal sensation to cold)

时间窗: 20 minutes post injection

Evaluation of sensitive block for the median nerve at 20 minutes post injection

Efficience of the block assessed by number of block sufficient for surgery

时间窗: Immediately after procedure

Is the block enough for surgery or must be completed

Evaluation of motor block for the median nerve at 5 minutes post injection assessed by a scale of motor function (0 = Complete paresis, 1 = Partial paresis, 2 = Normal motion)

时间窗: 5 minutes post injection

Evaluation of motor block for the median nerve

Evaluation of motor block for the median nerve at 20 minutes post injection assessed by a scale of motor function (0 = Complete paresis, 1 = Partial paresis, 2 = Normal motion)

时间窗: 20 minutes post injection

Evaluation of motor block for the median nerve

Evaluation of motor block for the ulnar nerve at 10 minutes post injection assessed by a scale of motor function (0 = Complete paresis, 1 = Partial paresis, 2 = Normal motion)

时间窗: 10 minutes post injection

Evaluation of motor block for the ulnar nerve

Evaluation of motor block for the ulnar nerve at 15 minutes post injection assessed by a scale of motor function (0 = Complete paresis, 1 = Partial paresis, 2 = Normal motion)

时间窗: 15 minutes post injection

Evaluation of motor block for the ulnar nerve

Feasibility of block realisation assessed by number of abandonned block

时间窗: Immediately after procedure

Difficulty in the block realisation (block abandonned before or during realisation)

Evaluation of motor block for the median nerve at 15 minutes post injection assessed by a scale of motor function (0 = Complete paresis, 1 = Partial paresis, 2 = Normal motion)

时间窗: 15 minutes post injection

Evaluation of motor block for the median nerve

Comfort during block realization assessed by Numeric Rating Scale (NRS - 0 = No pain, 10 = worse pain)

时间窗: Immediately after procedure

Evaluation of comfort during block realization

Evaluation of motor block for the ulnar nerve at 20 minutes post injection assessed by a scale of motor function (0 = Complete paresis, 1 = Partial paresis, 2 = Normal motion)

时间窗: 20 minutes post injection

Evaluation of motor block for the ulnar nerve

Evaluation of motor block for the ulnar nerve at 5 minutes post injection assessed by a scale of motor function (0 = Complete paresis, 1 = Partial paresis, 2 = Normal motion)

时间窗: 5 minutes post injection

Evaluation of motor block for the ulnar nerve

Evaluation of motor block for the musculocutaneous nerve at 10 minutes post injection assessed by a scale of motor function (0 = Complete paresis, 1 = Partial paresis, 2 = Normal motion)

时间窗: 10 minutes post injection

Evaluation of motor block for the musculocutaneous nerve

Evaluation of motor block for the radial nerve at 5 minutes post injection assessed by a scale of motor function (0 = Complete paresis, 1 = Partial paresis, 2 = Normal motion)

时间窗: 5 minutes post injection

Evaluation of motor block for the radial nerve

Evaluation of motor block for the radial nerve at 15 minutes post injection assessed by a scale of motor function (0 = Complete paresis, 1 = Partial paresis, 2 = Normal motion)

时间窗: 15 minutes post injection

Evaluation of motor block for the radial nerve

Evaluation of motor block for the radial nerve at 20 minutes post injection assessed by a scale of motor function (0 = Complete paresis, 1 = Partial paresis, 2 = Normal motion)

时间窗: 20 minutes post injection

Evaluation of motor block for the radial nerve

Evaluation of motor block for the musculocutaneous nerve at 5 minutes post injection assessed by a scale of motor function (0 = Complete paresis, 1 = Partial paresis, 2 = Normal motion)

时间窗: 5 minutes post injection

Evaluation of motor block for the musculocutaneous nerve

Evaluation of motor block for the musculocutaneous nerve at 15 minutes post injection assessed by a scale of motor function (0 = Complete paresis, 1 = Partial paresis, 2 = Normal motion)

时间窗: 15 minutes post injection

Evaluation of motor block for the musculocutaneous nerve

Evaluation of motor block for the musculocutaneous nerve at 20 minutes post injection assessed by a scale of motor function (0 = Complete paresis, 1 = Partial paresis, 2 = Normal motion)

时间窗: 20 minutes post injection

Evaluation of motor block for the musculocutaneous nerve

Evaluation of sensitive block for the ulnar nerve at 5 minutes post injection assessed by a scale of sensitive function (0 = No sensibilityto cold, 1 = partial insensibility to cold, 2 = Normal sensation to cold)

时间窗: 5 minutes post injection

Evaluation of sensitive block for the ulnar nerve at 5 minutes post injection

Evaluation of sensitive block for the ulnar nerve at 10 minutes post injection assessed by a scale of sensitive function (0 = No sensibilityto cold, 1 = partial insensibility to cold, 2 = Normal sensation to cold)

时间窗: 10 minutes post injection

Evaluation of sensitive block for the ulnar nerve at 10 minutes post injection

Evaluation of sensitive block for the ulnar nerve at 15 minutes post injection (0 = No sensibilityto cold, 1 = partial insensibility to cold, 2 = Normal sensation to cold)

时间窗: 15 minutes post injection

Evaluation of sensitive block for the ulnar nerve at 15 minutes post injection

Evaluation of sensitive block for the ulnar nerve at 20 minutes post injection assessed by a scale of sensitive function (0 = No sensibilityto cold, 1 = partial insensibility to cold, 2 = Normal sensation to cold)

时间窗: 20 minutes post injection

Evaluation of sensitive block for the ulnar nerve at 20 minutes post injection

Evaluation of sensitive block for the radial nerve at 5 minutes post injection assessed by a scale of sensitive function (0 = No sensibilityto cold, 1 = partial insensibility to cold, 2 = Normal sensation to cold)

时间窗: 5 minutes post injection

Evaluation of sensitive block for the radial nerve at 5 minutes post injection

Evaluation of sensitive block for the ulnar nerve at 15 minutes post injection assessed by a scale of sensitive function (0 = No sensibilityto cold, 1 = partial insensibility to cold, 2 = Normal sensation to cold)

时间窗: 15 minutes post injection

Evaluation of sensitive block for the ulnar nerve at 15 minutes post injection

Evaluation of sensitive block for the musculocutaneous nerve at 5 minutes post injection assessed by a scale of sensitive function (0 = No sensibilityto cold, 1 = partial insensibility to cold, 2 = Normal sensation to cold)

时间窗: 5 minutes post injection

valuation of sensitive block for the musculocutaneous nerve at 5 minutes post injection

Evaluation of sensitive block for the musculocutaneous nerve at 10 minutes post injection assessed by a scale of sensitive function (0 = No sensibilityto cold, 1 = partial insensibility to cold, 2 = Normal sensation to cold)

时间窗: 10 minutes post injection

Evaluation of sensitive block for the musculocutaneous nerve at 10 minutes post injection

Evaluation of sensitive block for the musculocutaneous nerve at 15 minutes post injection assessed by a scale of sensitive function (0 = No sensibilityto cold, 1 = partial insensibility to cold, 2 = Normal sensation to cold)

时间窗: 15 minutes post injection

Evaluation of sensitive block for the musculocutaneous nerve at 15 minutes post injection

Evaluation of sensitive block for the musculocutaneous nerve at 20 minutes post injection assessed by a scale of sensitive function (0 = No sensibilityto cold, 1 = partial insensibility to cold, 2 = Normal sensation to cold)

时间窗: 20 minutes post injection

Evaluation of sensitive block for the musculocutaneous nerve at 20 minutes post injection

次要结局

  • Demographic data AGE(At the time of the procedure)
  • Demographic data WEIGHT(At the time of the procedure)
  • Demographic data HEIGHT(At the time of the procedure)
  • Type of surgery(At the time of the procedure)
  • Tourniquet(At the time of the procedure)
  • Type of hospitalization(At the time of the procedure)
  • Local anesthetics used(At the time of the procedure)
  • Operator impression(At the time of the procedure)
  • Incident during block performance(At the time of the procedure)
  • Duration of block performance(At the time of the procedure)
  • Duration of motor block(from 0 to day 1)
  • Duration of sensitive block(from 0 to day 1)
  • Block injury(From day 0 to day 7)
  • Comparative image axillary and novel point of puncture(During the procedure)

研究者

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

J P Lecoq

Medical Doctor

University of Liege

研究点 (2)

Loading locations...

相似试验