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临床试验/CTRI/2025/03/083505
CTRI/2025/03/083505尚未招募3 期

Sequential Administration Of Dual Or Single Injection Of Local Anaesthetic For Continuous Infraclavicular Block-Does It Make A Difference?-A Randomized Controlled Trial

Christian medical college1 个研究点 分布在 1 个国家目标入组 174 人开始时间: 2025年4月1日最近更新:

试验速览

阶段
3 期
状态
尚未招募
入组人数
174
试验地点
1
主要终点
onset of sensory blockade

研究概览

简要总结

Local anaesthetic drugs are classified according to the duration of action as short, intermediate and long-acting drugs. Combining different classes of local anaesthetic drugs for peripheral nerve blocks has faster onset and prolonged duration of action. The purpose of this double blinded randomized controlled study is to compare onset and duration of action between sequential administration of one drug and a mixture of two different drugs , in terms of onset and duration, however, the same pharmacological groups of local anaesthetic drugs, for ultrasound guided infraclavicular approach with to brachial plexus block. An infraclavicular approach to the brachial plexus block can be used for surgical procedures below the mid humerus. It has gained popularity because of its ease of performance and the ability to simultaneously anaesthetize the axillary, musculocutaneous, median, radial and ulnar nerves. The block can be done with minimal risk of pneumothorax and other complications such as block of the phrenic nerve or stellate ganglion. An infraclavicular approach to brachial plexus block provides sufficient anaesthetic and analgesic effect for below-elbow and hand surgeries. Infraclavicular approach is not only advantageous for inserting a perineural catheter, but also has a short procedure time compared to other approaches including supraclavicular and axillary approaches especially using ultrasound guidance

Group A- will receive 10ml 0.5% Ropivacine+10 ml 0.5% Ropivacaine

Group B- will receive 10ml 1% Lignocaine+10 ml 0.5% Ropivacaine

Post procedure the onset of block is assessed by recording the sensory and motor blockade by time to complete loss of sensation and complete loss of motor power, need for intraoperative surgical anaesthesia and analgesia, is recorded and duration of block is assessed by time to rescue analgesia.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • Patients with ASA I, II, III undergoing elective below-elbow and hand surgery aged between 18-75years Either sex.

排除标准

  • patient with significant neurological, psychiatric, or neuromuscular disease suspected coagulopathy morbid obesity chronic renal failure cardiopulmonary compromise cerebral vascular disease local infection at the site of the infraclavicular block pregnant women and children.

结局指标

主要结局

onset of sensory blockade

时间窗: sensory onset is assessed in minutes every 30 seconds until achieved | motor onset is assessed in minutes every 5 minutes until achieved | duration of sensory and motor blockade is assessed every 2 hours till 12 hours and every 4 hours till 24 hours

onset of motor blockade

时间窗: sensory onset is assessed in minutes every 30 seconds until achieved | motor onset is assessed in minutes every 5 minutes until achieved | duration of sensory and motor blockade is assessed every 2 hours till 12 hours and every 4 hours till 24 hours

duration of sensory blockade

时间窗: sensory onset is assessed in minutes every 30 seconds until achieved | motor onset is assessed in minutes every 5 minutes until achieved | duration of sensory and motor blockade is assessed every 2 hours till 12 hours and every 4 hours till 24 hours

duration of motor blockade

时间窗: sensory onset is assessed in minutes every 30 seconds until achieved | motor onset is assessed in minutes every 5 minutes until achieved | duration of sensory and motor blockade is assessed every 2 hours till 12 hours and every 4 hours till 24 hours

次要结局

  • intraoperative use of analgesics & complications(baseline)

研究者

申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Kousalya G

Christian Medical College,Vellore

研究点 (1)

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