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CTRI Number  CTRI/2019/09/021416 [Registered on: 25/09/2019] Trial Registered Prospectively
Last Modified On: 10/01/2022
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Questionnaire Based Study 
Study Design  Single Arm Study 
Public Title of Study   Survey for regional anaesthesia practices in eastern India. 
Scientific Title of Study   Epidemiology, diversities and difference in regional Anaesthesia Practices in eastern India. 
Trial Acronym  Regional Survey 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR NEHA SINGH 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences, Bhubaneswar 
Address  Department of Anaesthesiology All India Institute of Medical Sciences, Sijua, Patrapada, Bhubaneswar,

Khordha
ORISSA
751019
India 
Phone  9438884045  
Fax    
Email  anaes_neha@aiimsbhubaneswar.edu.in  
 
Details of Contact Person
Scientific Query  
Name  DR NEHA SINGH 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences, Bhubaneswar 
Address  Department of Anaesthesiology All India Institute of Medical Sciences, Sijua, Patrapada, Bhubaneswar,

Khordha
ORISSA
751019
India 
Phone  9438884045  
Fax    
Email  anaes_neha@aiimsbhubaneswar.edu.in  
 
Details of Contact Person
Public Query  
Name  DR NEHA SINGH 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences, Bhubaneswar 
Address  Department of Anaesthesiology All India Institute of Medical Sciences, Sijua, Patrapada, Bhubaneswar,

Khordha
ORISSA
751019
India 
Phone  9438884045  
Fax    
Email  anaes_neha@aiimsbhubaneswar.edu.in  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences Bhubaneswar 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences Bhubaneswar 
Address  Department of Anaesthesiology All India Institute of Medical Sciences, Sijua, Patrapada, Bhubaneswar, Pin-751019  
Type of Sponsor  Research institution 
 
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 Neha Singh  All India Institute of Medical Sciences, Bhubaneswar  Room No. 154, Department of Anaesthesiology All India Institute of Medical Sciences, Sijua, Patrapada, Bhubaneswar, Pin-751019
Khordha
ORISSA 		 9438884045

anaes_neha@aiimsbhubaneswar.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, All India Institute of Medical Sciences, Bhubaneswar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Anaesthesiologists practicing regional blocks at Eastern India 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Anaesthesiologists practicing Regional blocks at Eastern India. 
 
ExclusionCriteria 
Details  Refusal to take part in the study. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To look for the present trends and use of regional block practices in eastern India.  After completion of the survey. 
 
Secondary Outcome  
Outcome  TimePoints 
To look for the reasons for hesitancy in using regional block techniques.  After completion of the survey. 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   30/09/2019 
Date of Study Completion (India) 10/01/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   none 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  
Regional anaesthesia is a part of perioperative medicine and recent studies have suggested that regional anaesthetic techniques can have significant impact on both perioperative and long-term outcomes.(1) Epidemiological studies help to tell us about trends and disparities in the study area but epidemiological research in anaesthesia is not much popular. Few population-based research has suggested that patients receiving neuraxial vs general anaesthesia (GA) can have improved medical and economic outcomes, including fewer adverse respiratory events, infections, blood transfusions, and intensive care unit admissions.(2,3) We have paucity of the Indian data on usage and acceptability of regional anaesthesia. We need large patient cohort representative from different parts of the India to look for the trends and practices in regional anaesthesia practices.
After approval from institutional ethics committee and written informed consent, anaesthesiologists attending a regional anaesthesia conference will be enrolled.A self-made Questionnaire comprising of 15 questions to collect the data pertaining to demographic details, regional techniques, and drugs used by anaesthesiologist from eastern india.For data collection, structured questionnaires in English will be used.
References:
1. Kessler J, Marhofer P, Hopkins PM, Hollmann MW. Peripheral regional anaesthesia and outcome: lessons learned from the last 10 years. Br J Anaesth. 2015 May;114(5):728-45.

2. Liu J, Ma C, Elkassabany N, Fleisher LA, Neuman MD. Neuraxial anesthesia decreases postoperative systemic infection risk compared with general anesthesia in knee arthroplasty. Anesth Analg. 2013 Oct;117(4):1010-6.

3.  Opperer M, Danninger T, Stundner O, Memtsoudis SG.  Perioperative outcomes and type of anesthesia in hip surgical patients: An evidence based review. World J Orthop. 2014 Jul 18;5(3):336-43.

 
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