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Clinical Trials/CTRI/2024/01/061745
CTRI/2024/01/061745Not yet recruitingPhase 3

Comparing Efficacy Of Perineural Versus Intravenous Dexmedetomidine as an Adjuvant to 0.5 % Levobupivacaine in ultrasound guided Supraclavicular Brachial Plexus Block in Upper Limb Surgeries in Department of Anaesthesia at SMS Hospital ,Jaipur

Sawai Man Singh Medical College and Hospital1 site in 1 country100 target enrollmentStarted: January 26, 2024Last updated:

Trial Snapshot

Phase
Phase 3
Status
Not yet recruiting
Sponsor
Enrollment
100
Locations
1
Primary Endpoint
To assess and compare the difference in mean duration of analgesia in both

Study Overview

Brief Summary

In this study we plan to study and draw comparison of effect of dexmedetomidine when given near nerves versus when given intravenous.

The study will be conducted in following two groups of patients. Study will consist of 100 patients. GROUP A  50 patients will receive Perineural 25ml 0.5% Levobupivacaine plus 1mcg/kg Dexmedetomidine diluted in 2ml NS for ultrasound guided supraclavicular brachial plexus block. along with IV 50 ml Normal saline administered as infusion over 10 minutes.  GROUP B 50 patients will receive  Perineural: 25ml 0.5% Levobupivacaine plus 2ml NS for ultrasound guided supraclavicular brachial plexus block  IV 1 μg/kg-1 dexmedetomidine in 50 mL of normal saline administered as infusion over 10 minutes

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant and Investigator Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Patients who Will give informed written consent Either sex American Society of Anesthesiologists Physical Status (ASA-PS) Classes I and II Posted for upper limb surgeries Body weight :– 40-70 kg.

Exclusion Criteria

  • Patients having severe systemic illness and bleeding disorders, Pregnant women Patients allergic to study drugs Patients having peripheral neuropathy or motor neuron disorders Patients having pathology at infection site Disability limiting the preferences of block.

Outcomes

Primary Outcomes

To assess and compare the difference in mean duration of analgesia in both

Time Frame: 0,5,10,15,20,25,30,45,60,75,90 minutes

the groups.

Time Frame: 0,5,10,15,20,25,30,45,60,75,90 minutes

Secondary Outcomes

  • Onset of sensory block (minutes)(Onset of motor block (minutes))

Investigators

Sponsor
Sawai Man Singh Medical College and Hospital
Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

Dr Poonam Kalra

Sawai Man Singh Medical College

Study Sites (1)

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