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CTRI Number  CTRI/2025/12/098609 [Registered on: 08/12/2025] Trial Registered Prospectively
Last Modified On: 07/12/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study to evaluate use of photos and videos for positioning for spinal anaesthesia 
Scientific Title of Study   Randomised control trial to evaluate and compare effect of videographic and photographic visual aid use on optimal positioning for spinal anaesthesia 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Pakhare Vandana 
Designation  Assistant professor 
Affiliation  ESIC Medical college and Hospital, Sanathnagar, Hyderabad 
Address  3021, 3rd floor, department of anaesthesia, esic medical college

Hyderabad
TELANGANA
500038
India 
Phone  8978827702  
Fax    
Email  vandanapakhare@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Pakhare Vandana 
Designation  Assistant professor 
Affiliation  ESIC Medical college and Hospital, Sanathnagar, Hyderabad 
Address  3021, 3rd floor, department of anaesthesia, esic medical college

Hyderabad
TELANGANA
500038
India 
Phone  8978827702  
Fax    
Email  vandanapakhare@gmail.com  
 
Details of Contact Person
Public Query  
Name  Pakhare Vandana 
Designation  Assistant professor 
Affiliation  ESIC Medical college and Hospital, Sanathnagar, Hyderabad 
Address  3021, 3rd floor, department of anaesthesia, esic medical college

Hyderabad
TELANGANA
500038
India 
Phone  8978827702  
Fax    
Email  vandanapakhare@gmail.com  
 
Source of Monetary or Material Support  
ESIC medical college, 3021, 3rd floor, department of anaesthesia, sanathnagar, hyderabad, telangana. 500038 
 
Primary Sponsor  
Name  ESIC MEDICAL COLLEGE 
Address  3021, 3rd floor, department of anaesthesia, sanathnagar, hyderabad, telangana. 500038 
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 
vandana Pakhare  ESIC medical college  3021, 3rd floor operation theatre complex, department of anaesthesia, esic medical college hospital sanathnagar hyderabad 500038
Hyderabad
TELANGANA 		 8978827702

vandanapakhare@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K402||Bilateral inguinal hernia, withoutobstruction or gangrene,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Media  Photograph and videograph of correct position for spinal anaesthesai 
Comparator Agent  verbal commands  standard verbal commands will be given to position patinet 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA I and II patients undergoing infraumbilical surgery including inguinal hernia, hydrocoele repair, varicose vein, appendicectomy
Age 18-60 year
 
 
ExclusionCriteria 
Details  ASA III &IV , BMI more than 40 kg/m2
Contraindication to neuraxial anaesthesia
Previous experience with neuraxial anaesthesia
Patient refusal
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
time required for successful dural puncture   time from skin puncture to clear flow of csf  
 
Secondary Outcome  
Outcome  TimePoints 
first pass success number of skin punctures number of intervertebral spaces attempted change of needle gauze patient satisfaction & attending anaesthetist satisfaction  baseline 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   01/01/2026 
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="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  

Central neuraxial block anaesthesia is most frequently used anaesthetic technique owing to its benefits, availability and low risk profile. Patient positioning and quality of landmarks form the cornerstone of successful neuraxial anaesthesia.  Studies shows that use of visual aids in the form of photographs helps in optimal patient positioning resulting in reduced time for successful dural puncture, number of skin punctures and high first pass success rate. Demonstration of optimal position will further help in achieving optimal position for neuraxial block.

We aim to study the effect of use of visual aids in the form of video graph  showing demonstration of optimal position for neuraxial anaesthesia compared to photographs of optimal position. Our primary outcome is to compare time required for successful dural puncture and secondary outcomes are first pass success, number of skin punctures, number of intervertebral spaces attempted, change of needle gauze, patient satisfaction and attending anaesthetist satisfaction.

 
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