跳至主要内容
临床试验/CTRI/2024/09/074293
CTRI/2024/09/074293尚未招募Phase 3 4

Comparison of Hemidiaphragmetic paralysis in supraclavicular vs Infraclavicular brachial plexus block in adult patients undergoing elective brachial vein transposition

JSS ACADEMY OF HIGHER EDUCATION AND RESEARCH1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年11月10日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Assessment of Hemidiaphragmetic palsy in supraclavicular vs infraclavicular brachial plexus block

研究概览

简要总结

Following approval from the Institutional Ethical committee,

Patients will be evaluated for the eligibility of the study , and written informed consents will be obtained from enrolled participants by the study team before surgery .

A thorough pre anesthetic evaluation will be done 24 hrs prior to the procedure.

Patients will be randomly assigned using shuffled sealed ,opaque enveloped technique at

ratio of 1:1into two groups .

GROUP (SC)- Supraclavicular brachial plexus block

GROUP(CC)- Costoclavicular block

ANESTHETIC PROCEDURES

Patients in the age group of 20-60 of either sex undergoing elective basilic vein

transposition under brachial plexus block will be enrolled for the study with written

informed consent

On the day of surgery, a single anesthesiologist performs either the supraclavicular or

infraclavicular block. Prior to 30 minutes of surgery sonographic assessment of diaphragm

motion and contraction will be done using “ABCDE “ method described by Tsui et all(2).Which is performed by placing the probe at zone of apposition of anterior Axillary line,

watching for breathing (lung sliding), then moving caudally to identify the diaphragm for

evaluation . An 20 G iv cannula will be inserted and the patient is connected to standard

monitors such as noninvasive blood pressure , electrocardiography [ECG] and pulse

oximetry[Sp02].

All blocks will be performed under ultrasound guidance (Logiq p6 pro ultrasound system

manufactured by GE healthcare) by a single experienced Anesthesiologist using linear

probe of frequency 15-20 hz (11L) at different locations . Each patient will be

administered mixture of 22 ml, out of which 10 ml is 0.5% Bupivacaine , 10ml is 2%

lignocaine with adrenaline. , Dexamethasone 4mg (1ml) and clonidine 150mcg. .

Adequacy of sensory and motor blockade will be assessed .After about 30 minutes of

observation the movement of Diaphragm will be assessed using Ultrasonography by

using the ‘ABCDE teqnique. Patient satisfaction and complications like vascular puncture

and pneumothorax will be assessed.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Outcome Assessor Blinded

入排标准

年龄范围
20.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients aged 20 to 60 years undergoing elective basilic vein transposition under brachial plexus block.

排除标准

  • Patient refusal 2) Hypersensitivity to amide anesthetic 3) Pre-existing neuropathy to surgical limb 4) significant pulmonary disease 5)coagulopathy 6) infection at block site.

结局指标

主要结局

Assessment of Hemidiaphragmetic palsy in supraclavicular vs infraclavicular brachial plexus block

时间窗: From the time of brachial plexus block to 4 hours later

次要结局

  • Adequacy of sensory, Motor blockade, Patient satisfaction, pulmonary complications(From the time of brachial plexus block to 4 hours later)

研究者

发起方
JSS ACADEMY OF HIGHER EDUCATION AND RESEARCH
申办方类型
Private medical college

研究点 (1)

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