Comparison between two types of regional upper limb blocks specifically for unilateral clavicle fracture repair.

Phase 1

Completed

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2024/06/068720
• Lead Sponsor: Shri BM Patil Medical College

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2024-02-06
• Study Start: 2024-06-15
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	30 minutes

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

BLDE MEDICAL COLLEGE; 🇮🇳 Bijapur, KARNATAKA, India

BLDE MEDICAL COLLEGE

🇮🇳Bijapur, KARNATAKA, India

Dr Unnithan Arya Gopinathan

Principal investigator

9074261410

dr.aryaunnithan@gmail.com