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临床试验/NCT05297422
NCT05297422Unknown不适用

Administration of Ketamine to Branchial Plexus Block Using Axillary Approach : Comparative Study

National and Kapodistrian University of Athens1 个研究点 分布在 1 个国家目标入组 81 人开始时间: 2022年1月20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
81
试验地点
1
主要终点
VAS (Visual Analog Scale) over 24 hours following intervention

研究概览

简要总结

The purpose of this study is to assess Ketamine as an adjuvant to Branchial Plexus Blockade.

详细描述

After being informed about the study, patients giving written informed consent will undergo anaesthesia using the Ultrasound Guided Axillary Approach to Brachial Plexus Blockade, in order to undergo forearm surgery. The purpose of this study is to assess whether Ketamine as an adjuvant lengthens sensory and motor blockade and whether it has an effect on "rebound pain" when the anaesthetic effect fades. Therefore the study will compare intravenous, regional and no administration of Ketamine as an adjuvant to Branchial Plexus Blockade. Patients will be asked to fill in a Pain VAS (Visual Analog Scale) for 24 hours following the intervention, in order to assess effectiveness of each anaesthetic method. Side effects, onset time, motor blockade score and rescue dose are also recorded.

研究设计

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

入排标准

年龄范围
16 Years 至 70 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • BMI 20-35
  • ASA score I, II, III

排除标准

  • Mental disorder
  • Peripheral neuropathy
  • Severe hepatic or renal disease
  • Gastrointestinal bleeding history

研究组 & 干预措施

Control

Active Comparator

Axillary Approach to Brachial Plexus Blockade will be performed using 30ml Ropivacaine 0.5% ,without Ketamine as an adjuvant.

干预措施: Forearm surgey (Procedure)

Control

Active Comparator

Axillary Approach to Brachial Plexus Blockade will be performed using 30ml Ropivacaine 0.5% ,without Ketamine as an adjuvant.

干预措施: Ropivacaine (Drug)

Ketamine IV

Active Comparator

Axillary Approach to Brachial Plexus Blockade will be performed using 30ml Ropivacaine 0.5% ,with Ketamine as an adjuvant 30mg intravenously.

干预措施: Forearm surgey (Procedure)

Ketamine IV

Active Comparator

Axillary Approach to Brachial Plexus Blockade will be performed using 30ml Ropivacaine 0.5% ,with Ketamine as an adjuvant 30mg intravenously.

干预措施: Ropivacaine (Drug)

Ketamine IV

Active Comparator

Axillary Approach to Brachial Plexus Blockade will be performed using 30ml Ropivacaine 0.5% ,with Ketamine as an adjuvant 30mg intravenously.

干预措施: Ketamine (Drug)

Ketamine Regional

Active Comparator

Axillary Approach to Brachial Plexus Blockade will be performed using 30ml Ropivacaine 0.5% ,with Ketamine as an adjuvant 30mg regionally.

干预措施: Forearm surgey (Procedure)

Ketamine Regional

Active Comparator

Axillary Approach to Brachial Plexus Blockade will be performed using 30ml Ropivacaine 0.5% ,with Ketamine as an adjuvant 30mg regionally.

干预措施: Ropivacaine (Drug)

Ketamine Regional

Active Comparator

Axillary Approach to Brachial Plexus Blockade will be performed using 30ml Ropivacaine 0.5% ,with Ketamine as an adjuvant 30mg regionally.

干预措施: Ketamine (Drug)

结局指标

主要结局

VAS (Visual Analog Scale) over 24 hours following intervention

时间窗: 24 hours

VAS scale is expressed in integer numbers ranging from 0-10, where 0=no pain, 10= excruciating pain.

次要结局

  • Motor Blockade Score(24 hours)
  • Side Effects(24 hours)
  • Anesthesia Onset time(24 hours)
  • Rescue Dose(24 hours)

研究者

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

Demetra Solomou

Anaesthesiology Resident at KAT and Masters Student at National and Kapodistrian University of Athens

National and Kapodistrian University of Athens

研究点 (1)

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