FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/07/070676 [Registered on: 16/07/2024] Trial Registered Prospectively
Last Modified On: 12/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective observational study 
Study Design  Other 
Public Title of Study   To evaluate ultrasound guided supraclavicular block in patients undergoing upper extremity surgery with traditional methods and perfusion index 
Scientific Title of Study   A prospective observational study to evaluate ultrasound guided supraclavicular block with traditional methods and perfusion index during upper extremity surgeries at SMS medical college and attached group of hospitals, Jaipur 
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 Rajni Mathur 
Designation  Senior Professor 
Affiliation  Sawai Man Singh Medical College and hospital 
Address  Department of Anaesthesiology Sawai Man Singh Medical College and hospital Jaipur Rajasthan India

Jaipur
RAJASTHAN
302004
India 
Phone  9829357194  
Fax    
Email  rajnimathur@hotmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rajni Mathur 
Designation  Senior Professor 
Affiliation  Sawai Man Singh Medical College and hospital 
Address  Department of Anaesthesiology Sawai Man Singh Medical College and hospital Jaipur Rajasthan India

Jaipur
RAJASTHAN
302004
India 
Phone  9829357194  
Fax    
Email  rajnimathur@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Shristi Mishra 
Designation  Resident Doctor 
Affiliation  Sawai Man Singh Medical College and hospital 
Address  Department of Anaesthesiology Sawai Man Singh Medical College and hospital Jaipur Rajasthan India

Jaipur
RAJASTHAN
302004
India 
Phone  8456862042  
Fax    
Email  mishrashristi96@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology, Sawai Man Singh medical college and hospital, Jaipur Rajasthan 302004 India 
 
Primary Sponsor  
Name  Sawai Man Singh medical college and hospital Jaipur 
Address  Department of Anaesthesiology Sawai Man Singh Medical College and hospital Jaipur 302004 Rajasthan India 
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 Rajni Mathur  Sawai Man Singh medical college and hospital  Operation Theatre Department of Anaesthesiology Sawai Man Singh Medical College and hospital Jaipur Rajasthan India
Jaipur
RAJASTHAN 		 9829357194

rajnimathur@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Office of Ethics Committee, SMS Medical College and hospital, Jaipur  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 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1)Patient for upper limb surgery under ultrasound guided supraclavicular block
2)patients consenting to participate
3)patients belonging to ASA physical status I and II 
 
ExclusionCriteria 
Details  1)patient should not be a part of any other study
2)patients with diabetes mellitus
3)patients with peripheral vascular disease
4)patients with allergy to local anaesthetics
5)patients with local site infection
6)patients with contraindications to brachial plexus block 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1) Changes in perfusion index (PI)
2) changes in intraoperative hemodynamic variables in terms of SBP, DBP, MAP and HR 		 1.5mins
2.10 mins
3.15 mins
4.20 mins
5.25 mins
6.30 mins
7.35 mins
8.40 mins
9.45 mins
10.50 mins
11.55 mins
12.60 mins 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   25/07/2024 
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="0"
Months="2"
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   This is an observational study and no intervention will be done on the patients. Supraclavicular block is the preferred anaesthetic technique for upper limb surgeries. Ultrasound guided supraclavicular block will be evaluated using traditional methods (pin prick test and modified Bromage score) and perfusion index. A total of 30 patients fulfilling inclusion criteria and consenting to participate will be included in the study. In the operation theatre, the baseline vitals and perfusion index of the patient will be recorded and ultrasound guided supraclavicular block will be performed using 20ml of 0.5% Ropivacaine. The sensory and motor block will be assessed using traditional methods every 2 minutes and the SBP, DBP, MAP, SPO2 and perfusion index of the patient will be noted every 5 minutes. Patient will be monitored intra- operatively for any complications. 
Close