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CTRI Number  CTRI/2026/02/102980 [Registered on: 04/02/2026] Trial Registered Prospectively
Last Modified On: 04/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Other 
Public Title of Study   Comparison of Femoral Nerve Block and Intravenous Pain Medication for Patient Positioning Before Spinal Anaesthesia in Thigh Bone Fracture Surgery 
Scientific Title of Study   Comparative Study Between Ultrasound Guided Femoral Nerve Block and Low Dose Intravenous Fentanyl For Positioning of the Patient Before Giving Subarachnoid Block in Surgeries for Fracture Neck of Femur. 
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 Vishal Lalani 
Designation  Resident Anaesthesiology  
Affiliation  Pacific Medical College And Hospital 
Address  Department Of Anesthesiology and Critical Care, Third Floor Pacific Medical College and Hospital, Bilo ka Bedla Udaipur Rajasthan Udaipur RAJASTHAN 313001 India

Udaipur
RAJASTHAN
313001
India 
Phone  9636534696  
Fax    
Email  Lalani851@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sameer Goyal  
Designation  Professor of Anaesthesia  
Affiliation  Pacific Medical College and Hospital  
Address  Department Of Anesthesiology and Critical Care, Third Floor Pacific Medical College and Hospital, Bilo ka Bedla Udaipur Rajasthan Udaipur RAJASTHAN 313001 India

Udaipur
RAJASTHAN
313001
India 
Phone  8890802830  
Fax    
Email  Sameergoy@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Sameer Goyal  
Designation  Professor of Anaesthesia  
Affiliation  Pacific Medical College and Hospital  
Address  Department Of Anesthesiology and Critical Care, Third Floor Pacific Medical College and Hospital, Bilo ka Bedla Udaipur Rajasthan Udaipur RAJASTHAN 313001 India

Udaipur
RAJASTHAN
313001
India 
Phone  8890802830  
Fax    
Email  Sameergoy@yahoo.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology and Critical Care,Third Floor,Pacific Medical College and Hospital Udaipur Rajasthan Pin Code313001 
 
Primary Sponsor  
Name  PACIFIC MEDICAL COLLEGE AND HOSPITAL UDAIPUR 
Address  Department of Anaesthesiology and Critical Care,Third Floor,Pacific Medical College and Hospital Udaipur Rajasthan Pin Code313001 
Type of Sponsor  Private 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 Vishal Lalani  Pacific Medical College And Hospital   Department Of Anesthesiology and Critical Care, Third Floor Pacific Medical College and Hospital, Bilo ka Bedla Udaipur Rajasthan Udaipur RAJASTHAN 313001 India
Udaipur
RAJASTHAN 		 9636534696

Lalani851@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee pacific medical college and hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S720||Fracture of head and neck of femur,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Intravenous Fentanyl   Patients will receive intravenous fentanyl at a dose of 1 microgram/kg body weight administered 5 minutes before positioning for subarachnoid block. 
Intervention  Ultrasound guided femoral nerve block  Ultrasound-guided femoral nerve block will be administered using 12 mL of 0.5% bupivacaine under strict aseptic precautions 5–10 minutes before positioning the patient for subarachnoid block. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1) Adult patients aged between 18 and 80 years
2) ASA physical grade I and II
3) Patients giving informed consent.
4) Patients with upper end femur fractures 
 
ExclusionCriteria 
Details  1. Patient giving negative consent.
2. Patient allergic to local anesthetics or opioids
3. Coagulopathy or anticoagulant therapy
4. Local infection at the block site
5. Pre-existing neurological deficits 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Pain during patient positioning for subarachnoid block assessed using Visual Analog Scale  10 minutes after administration of the study intervention (during positioning for subarachnoid block) 
 
Secondary Outcome  
Outcome  TimePoints 
Number of attempts required to successfully perform subarachnoid block Hemodynamic changes during positioning HR BP  Baseline before intervention & 5 to 10 minutes after administration of the study intervention during positioning 
 
Target Sample Size   Total Sample Size="68"
Sample Size from India="68" 
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)   20/02/2026 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 prospective randomized study compares ultrasound guided femoral nerve block with low-dose intravenous fentanyl for analgesia during patient positioning prior to subarachnoid block in upper end femur fracture surgeries. Pain during positioning by VAS score ease and time of spinal anesthesia hemodynamic stability and postoperative analgesic requirements will be assessed to determine the more effective and safer technique.


 
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