跳至主要内容
临床试验/CTRI/2022/10/046124
CTRI/2022/10/046124尚未招募不适用

Comparative evaluation of hemidiaphragmatic paresis after Interscalene Brachial Plexus, Anterior Suprascapular And Posterior Suprascapular Nerve Block in patients undergoing arthroscopic shoulder surgery

Vardhman Mahavir Medical College and Safdarjung Hospital1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2022年7月10日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
90
试验地点
1
主要终点
To compare the incidence of hemidiaphragmatic paresis after ultrasound guided interscalene brachial plexus, anterior suprascapular and posterior suprascapular nerve block as determined by Forced expiratory volume in first second, Forced vital capacity and diaphragmatic excursion

研究概览

简要总结

This is a randomized comparative study to compare the incidence of hemidiaphragmatic paresis and analgesic efficacy after Ultrasound guided interscalene brachial plexus, anterior suprascapular and posterior suprascapular nerve block in patients undergoing arthroscopic shoulder surgery under general anaesthesia with the hypothesis that the incidence of hemidiaphragmatic paresis is less after posterior approach of suprascapular nerve block as compared to anterior approach of suprascapular nerve block and interscalene brachial plexus block plexus in patients undergoing arthroscopic shoulder surgery while providing noninferior analgesia.

Primarily hemidiaphragmatic paresis is determined by Forced expiratory volume in first second, Forced vital capacity and diaphragmatic excursion at pre-block, post-block 30 minutes and 1st hour post-operatively. Secondarily analgesic efficacy is compared with regards to 1)Total fentanyl requirements during intraoperative period. 2)Numerical rating scale (NRS) pain score. 3)Time taken to first rescue analgesia demand. 4)Total tramadol consumption during first 24 hours of postoperative period. Numerical rating scale (NRS) pain score is measured at immediate post-operatively, 1st hour post-operatively, 6th hour post-operatively, 12th hour post-operatively and 24th hour post-operatively.

研究设计

研究类型
Interventional
分配方式
Permuted block randomization, fixed
盲法
Participant and Outcome Assessor 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

  • ASA-I or II physical status scheduled to undergo arthroscopic shoulder surgery.

排除标准

  • Patients with known case of coagulopathies or on anticoagulant therapy/infection at the proposed site of block/ known allergies to effect of local anesthetics/ Severe Hypertension/ Preexisting Neurological deficit in upper limbs / Preexisting lung diseases or hemidiaphragmatic dysfunction/ Duration of surgery more than 2 hours/ Arthroscopic Rotator cuff repair.

结局指标

主要结局

To compare the incidence of hemidiaphragmatic paresis after ultrasound guided interscalene brachial plexus, anterior suprascapular and posterior suprascapular nerve block as determined by Forced expiratory volume in first second, Forced vital capacity and diaphragmatic excursion

时间窗: Pre-block, Post-Block 30 minutes and 1sr hour post-operatively.

次要结局

  • To compare analgesic efficacy of interscalene brachial plexus, anterior suprascapular and posterior suprascapular nerve block with regards to 1)Total fentanyl requirements during intraoperative period 2)Numerical rating scale (NRS) pain score 3)Time taken to first rescue analgesia demand 4)Total tramadol consumption during first 24 hours of postoperative period(Numeric rating pain score at immediate Postop, 1st Hr postop, 6th Hr postop, 12th Hr postop and 24th hour postop.)

研究者

发起方
Vardhman Mahavir Medical College and Safdarjung Hospital
申办方类型
Government medical college

研究点 (1)

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