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CTRI Number  CTRI/2022/01/039798 [Registered on: 28/01/2022] Trial Registered Prospectively
Last Modified On: 28/01/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Other 
Public Title of Study   Compare Nerve block technique and opioid for better analgesia in leg fracture patients  
Scientific Title of Study   COMPARISON OF ULTRASOUND GUIDED FEMORAL NERVE BLOCK AND INTRAVENOUS FENTANYL FOR ANALGESIA IN PATIENTS WITH FRACTURE OF FEMUR FOR COMBINED SPINAL EPIDURAL ANAESTHESIA POSITIONING – A RANDOMIZED CONTROLLED STUDY 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Hanford Bernnon Rajkumar 
Designation  post gradutae 
Affiliation  Post graduate  
Address  Department of Anaesthesiology, Pondicherry institute of Medical Sciences, Ganapathichettikulam, Kalapet Pondicherry Pondicherry PONDICHERRY 605014 India
Department of Anaesthesiology, Pondicherry institute of Medical Sciences, Ganapathichettikulam, Kalapet Pondicherry Pondicherry PONDICHERRY 605014 India
Pondicherry
PONDICHERRY
605014
India 
Phone  9444463336  
Fax    
Email  hanfordbernon@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Nagalakshmi  
Designation  Associate professor  
Affiliation  Associate professor  
Address  Department of Anaesthesiology, Pondicherry institute of Medical Sciences, Ganapathichettikulam, Kalapet Pondicherry Pondicherry PONDICHERRY 605014 India
Department of Anaesthesiology, Pondicherry institute of Medical Sciences, Ganapathichettikulam, Kalapet Pondicherry Pondicherry PONDICHERRY 605014 India
Pondicherry
PONDICHERRY
605014
India 
Phone  9444463336  
Fax    
Email  vedha83@gmail.com  
 
Details of Contact Person
Public Query  
Name  Hanford Bernnon Rajkumar 
Designation  post gradutae 
Affiliation  Post graduate  
Address  Department of Anaesthesiology, Pondicherry institute of Medical Sciences, Ganapathichettikulam, Kalapet Pondicherry Pondicherry PONDICHERRY 605014 India
Department of Anaesthesiology, Pondicherry institute of Medical Sciences, Ganapathichettikulam, Kalapet Pondicherry Pondicherry PONDICHERRY 605014 India
Pondicherry
PONDICHERRY
605014
India 
Phone  9444463336  
Fax    
Email  hanfordbernon@gmail.com  
 
Source of Monetary or Material Support  
Pondicherry Institute of MEdical Sciences 
 
Primary Sponsor  
Name  Hanford Bernnon Rajkumar 
Address  department of anaesthesiology, PIMS, pondicherry 
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 
Hanford Bernnon Rajkumar  Pondicherry Institute of Medical Sciences   kalapet, puducherry
Pondicherry
PONDICHERRY 		 9444463336

hanfordbernon@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
PIMS Institute Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  IV Fentanyl   1mcg/kg IV 
Intervention  Ultrasound guided femoral nerve block   20 ml of 0.5% bupivacaine  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Patients with fracture of femur including fracture shaft of femur and fractur neck of femur.

2. Patients of age between 18 to 80 years under ASA I and II  
 
ExclusionCriteria 
Details  1. Patients with head injury and poor GCS

2. Patients with pelvic fracture and bilateral femur fracture

3. Patients with known allergy for local anaesthetics

4. Patients with bleeding tendencies or raised INR 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the pain using VAS score post femoral nerve block and post intravenous fentanyl administration for positioning patients with fracture femur for combined spinal epidural anaesthesia.   Before intervention, post intervention at 5 minutes interval for 15 minutes  
 
Secondary Outcome  
Outcome  TimePoints 
to compare the hemodynamics, to compare the time taken to position the patients for CSE, time taken to perform the CSE.  during the procedure of CSE 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
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   Phase 1 
Date of First Enrollment (India)   28/01/2022 
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   nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   In femur fractures the treatment available is surgical correction. for which central neuraxial blockade is the preferred anaesthetic option in most cases. due to severe pain it is difficult to position the patient for central neuraxial blockade.
there are several modalities available to alleviate pain in these patients such as parenteral drugs like NSAIDS, opioids, etc. apart from parenteral drugs several modalities like nerve blocks can also give an adequate analgesia. here we intended to compare intravenous Fentanyl at a dose of 1mcg/kg vs Ultrasound guided femoral nerve block with 20 ml of O.25% Bupivacaine 15 minutes prior to positioning for central neuraxial blockade.
 
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