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CTRI Number  CTRI/2025/03/081528 [Registered on: 03/03/2025] Trial Registered Prospectively
Last Modified On: 27/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Diagnostic 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Clinical Trial To Know The Benefits Of Ultrasonography In Spinal Anaesthesia Among Elderly Population 
Scientific Title of Study   Comparison of First Pass Success Rate in Spinal Anesthesia between Anatomical Landmark Technique and Pre-Procedure Ultrasound Technique in Geriatric Population - A Randomized Control Trial 
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 Pooja Ratnakar Vernekar 
Designation  DNB PG Resident 
Affiliation  Narayana Hrudayalaya Hospitals 
Address  Dept of Anaesthesiology, Mazumdar Shaw Medical Center - Narayana Hrudayalaya Hospitals Bommasandra Industrial area, Anekal Tq, Bangalore

Bangalore
KARNATAKA
560099
India 
Phone  9036372682  
Fax    
Email  poojarv2012@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rakesh R 
Designation  Associate Consultant 
Affiliation  Narayana Hrudayalaya Hospitals 
Address  Dept of Anaesthesiology, Mazumdar Shaw Medical Center -Narayana Hrudayalaya Hospitals Bommasandra Industrial area, Anekal Tq, Bangalore

Bangalore
KARNATAKA
560099
India 
Phone  9886670995  
Fax    
Email  rakeshrbmc@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Rakesh R 
Designation  Associate Consultant 
Affiliation  Narayana Hrudayalaya Hospitals 
Address  Dept of Anaesthesiology, Mazumdar Shaw Medical Center -Narayana Hrudayalaya Hospitals Bommasandra Industrial area, Anekal Tq, Bangalore

Bangalore
KARNATAKA
560099
India 
Phone  9886670995  
Fax    
Email  rakeshrbmc@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr Pooja Ratnakar Vernekar 
Address  Dept of Anaesthesiology, Mazumdar Shaw Medical Center - Narayana Hrudayalaya Hospitals Bommasandra Industrial area, Anekal Tq, Bangalore 
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 Pooja Ratnakar Vernekar  Mazumdar Shaw Medical Center - Narayana Hrudayalaya Hospitals  Dept of Anaesthesiology, Mazumdar Shaw Medical Center - Narayana Hrudayalaya Hospitals Bommasandra Industrial area, Anekal Tq, Bangalore
Bangalore
KARNATAKA 		 09036372682

poojarv2012@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Narayana Health Academic Ethics Committee  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  Spinal anesthesia  Conventional anatomical landmark-based marking of injection site 
Intervention  Spinal anesthesia  Pre procedure Ultrasound testing to mark appropriate injection site 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  requiring spinal anaesthesia for elective surgical procedures 
 
ExclusionCriteria 
Details  a. Patient in pain or discomfort who are unable to cooperate for an ultrasound scan.
b. Hemodynamically unstable patients in whom performing the scan can be difficult.
c. Patients who had underwent previous spinal surgeries
d. Patients with kyphoscoliosis
e. Patients who are not suitable for a spinal anaesthesia procedure
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Number of passes and attempts  During Spinal anaesthesia 
 
Secondary Outcome  
Outcome  TimePoints 
Procedure time  duration in seconds 
Pain during procedure  Numerical rating scale 
Complications  2 days 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   05/03/2025 
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="0"
Days="20" 
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 a randomized control trial to compare the outcomes of spinal anaesthesia in geriatric population between two techniques, a pre-procedure ultrasound technique versus the conventional anatomical landmark technique. The study also aims to know whether a pre-procedure ultrasonography reduces the complications of spinal anaesthesia.  50 subjects will be recruited for the study and will be allocated to either group based on computer generated randomization table. In Anatomical group (AG), spinal anaesthesia will be given by the anatomical landmark technique. In Ultrasound group (UG), spinal anaesthesia will be given after a pre-procedure ultrasound. Then, first pass success rate of spinal anaesthesia between two groups will be compared along with other parameters like procedure time, pain during procedure and complications between two groups.

 
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