CTRI/2023/09/058121Not yet recruitingPhase 1
A randomised clinical trial to compare the efficacy of single injection and triple injection using a Costoclavicular approach for infraclavicular brachial plexus block in upper limb surgery
Shri B M Patil medicaal college hospital and Reaseach centre1 site in 1 country90 target enrollmentStarted: October 15, 2023Last updated:
Trial Snapshot
- Phase
- Phase 1
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- To evaluate time to onset of Sensory and Motor block
Study Overview
Brief Summary
2 groups of patients were given Costoclavicular approach of brachial plexus block using 2 different techniques in each group. Time of onset of sensory and motor block was evaluated.Secondary outcomes include time to achieve complete sensory and motor block, performance time, duration of analgesia, adverse events and complications like vascular puncture, pleural puncture, paresthesia etc. Results of both the groups were monitored for block till 30 mins post surgery and for analgesia, till 24 hours.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Double Blind Double Dummy
Eligibility Criteria
- Ages
- 18.00 Year(s) to 55.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •A.S.A. grades I and II 2)Age 18 to 55 years 3)Body mass index of 18-35 kgm2.
Exclusion Criteria
- •Cardio-cerebrovascular diseases (history of heart failure, poor control of hypertension, coronary heart disease and cerebrovascular history) 2)Respiratory insufficiency (More than four rib fractures, obstructive lung disease like emphysema, C.O.P.D. etc.) 3)Abnormal blood coagulation 4)Puncture site infection 5)Allergy to local anaesthetics.
Outcomes
Primary Outcomes
To evaluate time to onset of Sensory and Motor block
Time Frame: 1 hour
Secondary Outcomes
- Time to achieve complete sensory and motor blockade (i.e surgical anaesthesia)(Performance time)
Investigators
Study Sites (1)
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