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临床试验/CTRI/2024/06/068720
CTRI/2024/06/068720已完成1 期

Comparative study on the efficacy of ultrasound guided clavipectoral fascial plane block vs interscalene brachial plexus block combined with superficial cervical plexus block in clavicle surgeries - A randomized clinical trial.

Shri BM Patil Medical College1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年6月15日最近更新:

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Superficial Cervical Plexus Block and Interscalene Brachial Plexus Block group as compared to Superficial Cervical Plexus Block and Clavipectoral Fascial Plane Block group using modified bromage scale

研究概览

简要总结

This is a randomized clinical trial type of study which compares efficacy of ultrasound guided clavipectoral fascial plane block versus interscalene brachial plexus block combined with superficial cervical plexus block in clavicle fractures. It consists total of 60 patients with 30 each in 2 groups namely "C" and "I". Group C will have Superficial cervical plexus block combined with Clavipectoral fascial plane block and group I includes superficial cervical plexus block combined with Interscalene brachial plexus block. Both groups will receive 20ml of 0.5% Ropivicaine without any adjuvants in patients posted for unilateral clavicle fractures surgeries using Sonosite ultrasound guidance. The study will be conducted in Shri BM Patil Medical College Hospital and Research Centre , Vijayapura, Karnataka in it’s Orthopedic OT complex. The primary objective is to asses the success rate of the block, ultrasonographic assessment of hemidiaghragmatic paresis by using sigh test and modified bromage scale to asses the upper limb function. The secondary objective is assessment of pain by using VAS score, time for first rescue analgesia, look for side effects including local anaesthetic systemic toxicity and Horner syndrome.

研究设计

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

入排标准

年龄范围
18.00 Year(s) 至 55.00 Year(s)(—)
性别
All

入选标准

  • •Unilateral clavicle fractures Asa, grade 1 and 2 Elective internal fixation Willing for proposed blocks.

排除标准

  • •Cardio-cerebrovascular diseases( history of heart failure, poor control of hypertension, coronary heart disease and cerebrovascular history) Respiratory insufficiency (more than 4 rib fractures,obstructive lung disease like emphysema, copd etc) Abnormal blood coagulation Puncture site infection Allergy to local anaesthetics.

结局指标

主要结局

Superficial Cervical Plexus Block and Interscalene Brachial Plexus Block group as compared to Superficial Cervical Plexus Block and Clavipectoral Fascial Plane Block group using modified bromage scale

时间窗: 30 minutes

次要结局

  • Visual Analogue Score at 6 12 and 24 hrs after surgery is more in Superficial Cervical Plexus Block and Interscalene Brachial Plexus Block group as compared to Superficial Cervical Plexus Block and Clavipectoral Fascial Plane Block group(24 hours)

研究者

发起方
Shri BM Patil Medical College
申办方类型
Private medical college

研究点 (1)

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