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Clinical Trials/CTRI/2024/06/068720
CTRI/2024/06/068720CompletedPhase 1

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 site in 1 country60 target enrollmentStarted: June 15, 2024Last updated:

Trial Snapshot

Phase
Phase 1
Status
Completed
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
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

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Computer generated randomization
Masking
Participant Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 55.00 Year(s) (—)
Sex
All

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.

Outcomes

Primary Outcomes

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

Time Frame: 30 minutes

Secondary Outcomes

  • 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)

Investigators

Sponsor
Shri BM Patil Medical College
Sponsor Class
Private medical college

Study Sites (1)

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