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CTRI Number  CTRI/2024/07/070842 [Registered on: 18/07/2024] Trial Registered Prospectively
Last Modified On: 18/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Patients undergoing upper limb surgeries will be randomly allocated for supraclavicular brachial plexus block either by USG guided or Peripheral nerve stimulator guided. 
Scientific Title of Study   comparison of nerve stimulator guided technique and ultrasound guided supraclavicular brachial plexus block in upper limb surgeries: an observational cross sectional study 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sushma Rani 
Designation  Junior Resident 
Affiliation  Rajendra Institute of Medical Sciences, Bariatu, Ranchi 
Address  Department of Anaesthesiology, Rajendra Institute of Medical Sciences, Bariatu, Ranchi, Jharkhand
Department of Anaesthesiology, Rajendra Institute of Medical Sciences, Bariatu, Ranchi, Jharkhand
Ranchi
JHARKHAND
834009
India 
Phone  7079643850  
Fax    
Email  drsushmasingh450@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ladhu Lakra 
Designation  Professor 
Affiliation  Rajendra Institute of Medical Sciences, Bariatu, Ranchi, Bariatu 
Address  Department of Anaesthesiology, Rajendra Institute of Medical Sciences, Bariatu, Ranchi, Jharkhand
Department of Anaesthesiology, Rajendra Institute of Medical Sciences, Bariatu, Ranchi, Jharkhand
Ranchi
JHARKHAND
834009
India 
Phone  9835160608  
Fax    
Email  dr.ladhulakra007@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Major Sourabh Kumar 
Designation  Assistant Professor 
Affiliation  Rajendra Institute of Medical Sciences, Bariatu, Ranchi 
Address  Department of Anaesthesiology, Rajendra Institute of Medical Sciences, Bariatu, Ranchi, Jharkhand
Department of Anaesthesiology, Rajendra Institute of Medical Sciences, Bariatu, Ranchi, Jharkhand
Ranchi
JHARKHAND
834009
India 
Phone  09162976054  
Fax    
Email  sourabh_bhu0@yahoo.co.in  
 
Source of Monetary or Material Support  
Rajendra Institute of Medical Sciences,Bariatu,Ranchi, Jharkhand, India, Pin code 834009  
 
Primary Sponsor  
Name  Rajendra Institute of Medical Sciences 
Address  Department of Anaesthesiology, Rajendra Institute of Medical Sciences, Bariatu, Ranchi, Jharkhand 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sushma Rani  RAJENDRA INSTITUTE OF MEDICAL SCIENCES  Department of Anesthesiology and Orthopaedic operation theatre, RIMS, Bariatu,Ranchi
Ranchi
JHARKHAND 		 07079643850

drsushmasingh450@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, RIMS, Ranchi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  nerve stimulator guided ultrasound block  supraclavicular block will be given by anaesthesist team working in orthopaedic operation theatre by inserting 20G insulated needle at one inch lateral to the insertion to the sternocleidomastoid on the clavicle with the PNS set to deliver 1.5-2.5mA current at 1Hz frequency and 0.1 m sec of pulse duration slowly until the twitch of shoulder and palpating finger will be seen by anaesthesist team then after the post intervention the time since block and duration of the blockade will be noted by the principal investigator. 
Comparator Agent  ultrasound guided supraclavicular block  supraclavicular block will be given by anaesthesist team working in orthopaedic operation theatre by visualising honeycombed hyper and hypoechoic structure latral to the subclavian artery above first rib and pleura by using ultrasound machine with 4cm linear transducer with a frequency of 5-10MHz through 20G needle which will be attached to 10cm iv extension line for injecting the drug which will be done by anaesthesist team then after the post intervention the time since block and the duration of blockade will be noted by the principal investigator. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  a) The patient giving written and informed consent for study.
b)Patients posted for upper limb surgeries.
c) Patients with ASA grade I and II.
d) Male and female patients aged between 18-65 years. 
 
ExclusionCriteria 
Details  a) Patients with cognitive impairment or communication problems.
b) Pregnant and lactating patients.
c) Patient refusal.
d) Patients with ASA grade III or IV.
e)Allergy to local anaesthetics.
f) Patients below 18 and above 65 years of age and total body weight less than equal to 50kg.
g) Patients with coagulopathy or peripheral neuropathy. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
onset of sensory and motor blockade  Time from removal of block needle to the onset of sensory and motor blockade-:
0min, 5min, 10min, 15min, 20min, 25min, 30min 
 
Secondary Outcome  
Outcome  TimePoints 
a)To record the hemodynamic parameters- systolic blood pressure, diastolic blood pressure, heart rate and MAP from the time since block has to be given.
b)To record the time taken for doing supraclavicular block by USG or PNS. 		 0 min after the blockade
5 min after the blockade
10 min after the blockade
15 min after the blockade
20 min after the blockade
25 min after the blockade
30 min after the blockade 
 
Target Sample Size   Total Sample Size="72"
Sample Size from India="72" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   09/08/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Patients undergoing upper limb surgeries will be randomly allocated for supraclavicular brachial plexus block either by USG guided or Peripheral nerve stimulator guided by the anaesthetic team posted in orthopaedic operation theatre and the time taken for the procedure ( brachial plexus block) and the time of onset and duration of sensory and motor blockade is noted by the anaesthetic team which is later analysed by me (principal investigator). 
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