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临床试验/CTRI/2025/05/087855
CTRI/2025/05/087855尚未招募4 期

Impact Of Interscalene Brachial Plexus Block Causing Hemidiphragmatic Paresis in Extrafascial And Intrafascial Injections : A Prospective Double Blind Randomized Clinical Study

Government Medical college,Baroda1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年1月9日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
70
试验地点
1
主要终点
Comparing the Hemidiaphragmatic paresis by measuring the percentage of reduction in diaphragmatic excursion with the help of M-mode ultrasonography.

研究概览

简要总结

The aim of study is to compare Extrafascial and intrafascial injections using interscalene approach of brachial plexus block causing hemidiphragmatic paresis in midshaft and distal humerus surgeries.in Group E , patients will be given interscalene nerve block via Extrafascial injection  under USG guidance.in Group I, patients will be given interscalene nerve block via Intrafascial injection under USG guidance.Total 15ml volume of drug solution will be prepared with 0-5% bupivacaine 15 ml with 5 microgram of Adrenaline (1:200000)The primary outcome is to compare hemidiaphragmatic paresis with M-mode ultrasonography befor / 30 minuts after the interscalere block.Secondary outcome, difference in Peak expiratony flow rate, Forced expiratory  Volume in /sec, change in respiratory rate., assesment of sensory block in terms of time to achieve complete effect and duration, and requirement of additional anaesthesia  in terms of IV Fentanyl, local infiltration, IV Ketamine and propofol will be observed for satisfactory  anaesthesia.Success rate  will be  calculated accordingly. Hemodynamic parameters such as pulse, mean arterial pressure, SPo2, ECG. perioperative complications.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Patient posted for mid shaft and distal humerus surgeries Age Group in the range of 18 to 65 years of either sex.
  • Weight in the range of 45 to 70 kilogram.
  • ASA grade 1 and 2 Duration of Surgery Less than 3 hours.
  • Patient able to give written and informed consent.

排除标准

  • Patient not willing for procedure.
  • Existing neurological deficit in the upper limb, history of neck surgery or radiotherapy severe pulmonary disease, chest deformity, Contraindications to peripheral nerve block(allergy to local anaesthetics, coagulopathy, infection in the area), and pregnancy.
  • Patients with significant history of drug or alcohol abuse, psychiatric illness.

结局指标

主要结局

Comparing the Hemidiaphragmatic paresis by measuring the percentage of reduction in diaphragmatic excursion with the help of M-mode ultrasonography.

时间窗: Before and 30 minutes after the interscalene block in all patients.

次要结局

  • To be observed for difference in(Peak expiratory flow rate)

研究者

发起方
Government Medical college,Baroda
申办方类型
Government medical college

研究点 (1)

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