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Clinical Trials/CTRI/2025/03/083505
CTRI/2025/03/083505
Not yet recruiting
Phase 3

Sequential Administration Of Dual Or Single Injection Of Local Anaesthetic For Continuous Infraclavicular Block-Does It Make A Difference?-A Randomized Controlled Trial

Christian medical college1 site in 1 country174 target enrollmentStarted: April 1, 2025Last updated:

Overview

Phase
Phase 3
Status
Not yet recruiting
Enrollment
174
Locations
1
Primary Endpoint
onset of sensory blockade

Overview

Brief Summary

Local anaesthetic drugs are classified according to the duration of action as short, intermediate and long-acting drugs. Combining different classes of local anaesthetic drugs for peripheral nerve blocks has faster onset and prolonged duration of action. The purpose of this double blinded randomized controlled study is to compare onset and duration of action between sequential administration of one drug and a mixture of two different drugs , in terms of onset and duration, however, the same pharmacological groups of local anaesthetic drugs, for ultrasound guided infraclavicular approach with to brachial plexus block. An infraclavicular approach to the brachial plexus block can be used for surgical procedures below the mid humerus. It has gained popularity because of its ease of performance and the ability to simultaneously anaesthetize the axillary, musculocutaneous, median, radial and ulnar nerves. The block can be done with minimal risk of pneumothorax and other complications such as block of the phrenic nerve or stellate ganglion. An infraclavicular approach to brachial plexus block provides sufficient anaesthetic and analgesic effect for below-elbow and hand surgeries. Infraclavicular approach is not only advantageous for inserting a perineural catheter, but also has a short procedure time compared to other approaches including supraclavicular and axillary approaches especially using ultrasound guidance

Group A- will receive 10ml 0.5% Ropivacine+10 ml 0.5% Ropivacaine

Group B- will receive 10ml 1% Lignocaine+10 ml 0.5% Ropivacaine

Post procedure the onset of block is assessed by recording the sensory and motor blockade by time to complete loss of sensation and complete loss of motor power, need for intraoperative surgical anaesthesia and analgesia, is recorded and duration of block is assessed by time to rescue analgesia.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant and Investigator Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 75.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Patients with ASA I, II, III undergoing elective below-elbow and hand surgery aged between 18-75years Either sex.

Exclusion Criteria

  • patient with significant neurological, psychiatric, or neuromuscular disease suspected coagulopathy morbid obesity chronic renal failure cardiopulmonary compromise cerebral vascular disease local infection at the site of the infraclavicular block pregnant women and children.

Outcomes

Primary Outcomes

onset of sensory blockade

Time Frame: sensory onset is assessed in minutes every 30 seconds until achieved | motor onset is assessed in minutes every 5 minutes until achieved | duration of sensory and motor blockade is assessed every 2 hours till 12 hours and every 4 hours till 24 hours

onset of motor blockade

Time Frame: sensory onset is assessed in minutes every 30 seconds until achieved | motor onset is assessed in minutes every 5 minutes until achieved | duration of sensory and motor blockade is assessed every 2 hours till 12 hours and every 4 hours till 24 hours

duration of sensory blockade

Time Frame: sensory onset is assessed in minutes every 30 seconds until achieved | motor onset is assessed in minutes every 5 minutes until achieved | duration of sensory and motor blockade is assessed every 2 hours till 12 hours and every 4 hours till 24 hours

duration of motor blockade

Time Frame: sensory onset is assessed in minutes every 30 seconds until achieved | motor onset is assessed in minutes every 5 minutes until achieved | duration of sensory and motor blockade is assessed every 2 hours till 12 hours and every 4 hours till 24 hours

Secondary Outcomes

  • intraoperative use of analgesics & complications(baseline)

Investigators

Sponsor Class
Private medical college
Responsible Party
Principal Investigator
Principal Investigator

Kousalya G

Christian Medical College,Vellore

Study Sites (1)

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