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CTRI Number  CTRI/2024/12/078474 [Registered on: 23/12/2024] Trial Registered Prospectively
Last Modified On: 04/04/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of landmark versus ultrasound guided technique for spinal anaesthesia. 
Scientific Title of Study   Comparison Of Landmark Versus Ultrasound Guided Lumbar Puncture Technique For Spinal Anaesthesia In Obese Patients. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kalariya Parthikkumar Mansukhlal 
Designation  Junior Resident  
Affiliation  Army Hospital Research and Referral, Delhi Cantt 
Address  Department of Anaesthesiology and Critical Care, Army Hospital Research and Referral, Delhi Cantt

South West
DELHI
110010
India 
Phone  9409454878  
Fax    
Email  PARTHIKK@YAHOO.IN  
 
Details of Contact Person
Scientific Query  
Name  Brig Dr Parmeet Bhatia 
Designation  Professor Anaesthesiology and Critical Care 
Affiliation  Army Hospital Research and Referral, Delhi Cantt 
Address  Department of Anaesthesiology and Critical Care, Army Hospital Research and Referral, Delhi Cantt

South West
DELHI
110010
India 
Phone  9815599269  
Fax    
Email  drparmeetbhatia@gmail.com  
 
Details of Contact Person
Public Query  
Name  Kalariya Parthikkumar Mansukhlal 
Designation  Junior Resident 
Affiliation  Army Hospital Research and Referral, Delhi Cantt 
Address  Department of Anaesthesiology and Critical Care, Army Hospital Research and Referral, Delhi Cantt

South West
DELHI
110010
India 
Phone  9409454878  
Fax    
Email  PARTHIKK@YAHOO.IN  
 
Source of Monetary or Material Support  
Army Hospital Research and Referral, Department of Anaesthesiology, Delhi Cantt, PIN 110010, India 
 
Primary Sponsor  
Name  Kalariya Parthikkumar Mansukhlal 
Address  Department of Anaesthesiology and Critical Care, Army Hospital Research and Referral, Delhi Cantt- 110010 
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 Kalariya Parthikkumar Mansukhlal  Army Hospital Research and Referral  Department of Anaesthesiology and Critical Care, 2nd Floor, Room No.2, Delhi Cantt 110010
South West
DELHI 		 9409454878

PARTHIKK@YAHOO.IN 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Army Hospital Research and Referral  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: U07-U07||Provisional assignment of new diseases of uncertain aetiology or emergency use (U00-U49),  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Landmark guided spinal anaesthesia  Traditional Landmark guided spinal anaesthesia duration is just prior to starting of surgery 
Intervention  Ultrasound guided spinal anaesthesia  Ultrasonography to be done prior to giving spinal anaesthesia. Duration is just prior to administration of drug 
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  BMI more than 30 kg/m2, patients undergoing surgery under neuraxial block, patients giving valid informed consent 
 
ExclusionCriteria 
Details  Patient refusal, patients with spinal deformities, neurological diseases, coagulation disorders, local infection, unstable hemodynamics 
 
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 
To evaluate the mean difference of puncture attempts in ultrasound guided and landmark guided techniques for spinal anaesthesia in obese patients.  baseline 
 
Secondary Outcome  
Outcome  TimePoints 
to compare both groups in terms of first attempt success rate, dural puncture time, total procedural time and numbers of traumatic taps  baseline 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "68"
Final Enrollment numbers achieved (India)="68" 
Phase of Trial   N/A 
Date of First Enrollment (India)   23/12/2024 
Date of Study Completion (India) 31/08/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 31/08/2025 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
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   Obesity poses special considerations in the medicine especially during anaesthetic procedures due to change in anatomical and physiological status. However, in obese individual lumbar puncture is technically difficult because of increased subcutaneous fat and reduced visibility of typical landmark structures. In these patients the traditional lumbar puncture method is more difficult, greatly increasing the possibility of failure leads to more attempts at location, increased patient discomfort, nerve injury and post-dural puncture headache. In this study the comparison of the landmark-based technique and ultrasound-guided technique was conducted based on several criteria and differences were noted with regard to both technical and clinical aspects. In this perspective, we hypothesized that Ultrasound-guided spinal anaesthesia would result in reduced puncture attempts and improved success rates at first attempt when compared with the conventional landmark-guided technique in obese patients. 
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