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临床试验/NCT01993290
NCT01993290已完成不适用

Ultrasound-guided Brachial Plexus Block With the Single-penetration Multiple-injection-technique for Upper Extremity Surgery

Jens Borglum Neimann1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2013年4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
120
试验地点
1
主要终点
Blockade performance time (seconds)

研究概览

简要总结

Ultrasound-guided (USG) brachial plexus (BP) block efficacy at the Supraclavicular (SCL), Lateral- Infraclavicular (LIC) and Axillary (AX) level: Randomized, observer-blinded study of the single-penetration multiple-injection-technique.

详细描述

The investigators will compare the BP block efficacy (for surgical anaesthesia) with the USG single-penetration multiple-injection-technique at the SCL, LIC and AX level for upper-extremity surgery (elbow, forearm, wrist, hand). The investigators want to investigate whether the single-penetration multiple-injection-technique would provide for safe surgical anaesthesia with lower volumes of local anaesthetics than has previously been described in a comparative study at the three different levels.

120 patients will prospectively be randomized to an USG BP block administered as a single-penetration multiple-injection-technique at one of three different levels: (1) SCL (2) LIC (3) AX. Ropivacaine 0.75% (20 mL) will be used for all blocks prior to surgery.

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
Single (Outcomes Assessor)

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

  • Age above 18 years
  • American Society of Anaesthesiology class 1-3
  • Patients undergoing upper extremity surgery

排除标准

  • Inability to cooperate
  • Inability to understand and talk danish
  • Allergic to ropivacaine
  • Infection at site of surgery
  • Neurological dysfunction at site of surgery
  • Severe coagulopathy
  • Drug and alcohol abuse
  • Patients, who can not get a nerve block due to technical difficulty
  • Pregnancy or nursing
  • Body mass index >35

研究组 & 干预措施

USG Supraclavicular block

Active Comparator

20 ml of ropivacaine 0,75% is administered to brachial plexus at supraclavicular level.

干预措施: Ropivacaine (Drug)

Lateral infraclavicular block

Active Comparator

20 ml of ropivacaine 0,75 % is administered to brachialis plexus at lateral infraclavicular level

干预措施: Ropivacaine (Drug)

USG Axillaris block

Active Comparator

20 ml of ropivacaine 0,75% is administered to plexus brachialis at axillaris level

干预措施: Ropivacaine (Drug)

结局指标

主要结局

Blockade performance time (seconds)

时间窗: Time (seconds) from the time the ultrasound transducer is placed on the skin and until the needle is taken out of the body.

次要结局

  • Duration of time of block postoperatively (hours)(Patient reported the time off ending sensory and motory block)
  • Onset time of blockade (minutes)(Time from block completion to complete sensory and motor block is accomplished.)
  • Number of needle passes(Number of times the direction of the needle changes while performing the block)
  • Patient reported pain related to needle passes (Scale 0-2)(Pain related to block performance reported by the patient right after block completion)

研究者

发起方
Jens Borglum Neimann
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jens Borglum Neimann

Associate professor

Bispebjerg Hospital

研究点 (1)

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