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CTRI Number  CTRI/2024/03/064605 [Registered on: 21/03/2024] Trial Registered Prospectively
Last Modified On: 18/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   in this study we will compare between the pain relief provided by intravenous opioid and use of local anesthesia using ultrasound.  
Scientific Title of Study   Comparative study of analgesic efficacy of ultrasound guided femoral nerve block and intravenous fentanyl for positioning during spinal anesthesia for fracture femur 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
IEC KMC MLR 05/2023/192  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Jeya Kumar 
Designation  Junior Resident 
Affiliation  Junior Resident 
Address  Department of Anaesthesiology Kasturba Medical College Lighthouse Hill Road Mangalore Dakshina Kannada Karnataka Dakshina Kannada KARNATAKA 575003 India
Department of Anaesthesiology Kasturba Medical College Lighthouse Hill Road Mangalore Dakshina Kannada Karnataka Dakshina Kannada KARNATAKA 575003 India
Dakshina Kannada
KARNATAKA
575003
India 
Phone  9363662035  
Fax    
Email  jeyakumar1992pmk@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Padmanabha K 
Designation  Associate professor 
Affiliation  Kasturba Medical College Mangalore 
Address  Department of Anaesthesiology Kasturba Medical College Lighthouse Hill Road Mangalore Dakshina Kannada Karnataka Dakshina Kannada KARNATAKA 575003 India

Dakshina Kannada
KARNATAKA
575003
India 
Phone  9880094661  
Fax    
Email  padmanabha.k@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Padmanabha K 
Designation  Associate professor 
Affiliation  Kasturba Medical College Mangalore 
Address  Department of Anaesthesiology Kasturba Medical College Lighthouse Hill Road Mangalore Dakshina Kannada Karnataka Dakshina Kannada KARNATAKA 575003 India

Dakshina Kannada
KARNATAKA
575003
India 
Phone  9880094661  
Fax    
Email  padmanabha.k@manipal.edu  
 
Source of Monetary or Material Support  
Manipal Academy of Higher Education Manipal, Dakshina Kannada, Karnataka,576104 
 
Primary Sponsor  
Name  Dr Jeya Kumar 
Address  Department of Anesthesiology Kasturba Medical College Light House Hill Road Mangalore 575001 
Type of Sponsor  Other [Self] 
 
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 Jeya Kumar  Kasturba Medical College Mangalore  6th floor Department of Anaesthesiology Kasturba medical college Attavar Mangalore pin-575003 Dakshina Kannada Karnataka
Dakshina Kannada
KARNATAKA 		 8489200161

jeyakumar1992pmk@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Commitee, Kasturba Medical College Mangalore  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  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1) All patients of both genders between 18 to 70 years of age
2) All patients with American Society Of Anesthesiologists grade
I II III
3) Patients with fracture femur who undergo fixation under spinal anesthesia 
 
ExclusionCriteria 
Details  1) Patients with multiple fractures
2) Unconscious patients
3) Patients not willing to participate 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1) Pain scoring during positioning  Immediately 
 
Secondary Outcome  
Outcome  TimePoints 
1) Intra operative hemodynamic parameters
2) Post operative nausea and vomiting
3) Anesthesiologist satisfaction with the patient position maintained for a spinal block 		 1) Immediately
2) Through out intraoperative period 
 
Target Sample Size   Total Sample Size="104"
Sample Size from India="104" 
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)   10/04/2024 
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="3"
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   Compare the analgesic effect provided by ultrasound guided femoral nerve block and intravenous fentanyl  before positioning for central neuraxial block in patients undergoing surgery for fracture femur , at the same time record the intraoperative hemodynamic parameters , and quality of the patient during positioning. 
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