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CTRI Number  CTRI/2026/01/102625 [Registered on: 30/01/2026] Trial Registered Prospectively
Last Modified On: 29/01/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Finding the relation between existing formulas to that of actual measurment at lumbar region in paitents undergoing surgery under spinal anaesthesia 
Scientific Title of Study   Correlation of subarachnoid space depth obtained from formula versus actual measurement at lumbar region to derive appropriate formula in patients undergoing spinal anaesthesia at a tertiary care centre- An observational study 
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 YATHISH S K  
Designation  ASSISTANT PROFESSOR  
Affiliation  Bangalore medical college and research institute  
Address  Department of anaesthesia Bangalore medical college and research institute Bangalore
Department of anaesthesia Bangalore medical college and research institute Bangalore
Bangalore
KARNATAKA
560002
India 
Phone  7338595885  
Fax    
Email  skyathish86@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR YATHISH S K  
Designation  ASSISTANT PROFESSOR  
Affiliation  Bangalore medical college and research institute  
Address  Department of anaesthesia Bangalore medical college and research institute Bangalore
Department of anaesthesia Bangalore medical college and research institute Bangalore
Bangalore
KARNATAKA
560002
India 
Phone  7338595885  
Fax    
Email  skyathish86@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR YATHISH S K  
Designation  ASSISTANT PROFESSOR  
Affiliation  Bangalore medical college and research institute  
Address  Department of anaesthesia Bangalore medical college and research institute Bangalore
Department of anaesthesia Bangalore medical college and research institute Bangalore

KARNATAKA
560002
India 
Phone  7338595885  
Fax    
Email  skyathish86@gmail.com  
 
Source of Monetary or Material Support  
Bangalore medical college and research institute fort road KR market Bangalore karnataka India 560006  
 
Primary Sponsor  
Name  Bangalore medical college and research institute 
Address  Bangalore medical college and research institute fort rajendra road kalasipalya Bangalore 
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 
Dr yathish s k   Major operation theater complex department of anaesthesia   Department of anaesthesia Bangalore medical college and research institute Bangalore
Bangalore
KARNATAKA 		 7338595885

skyathish86@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethical committee of Bangalore college and research institute   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 
Intervention  spinal anaesthesia   spinal anaesthesia is given in lumbar space and the depth of the needle from skin to subarachnoid space is noted . 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA grade I/II patients posted for various elective surgeries under spinal anaesthesia in general, gynecology and obstetrics surgery unit. 
 
ExclusionCriteria 
Details  1.Patients with known hypersensitivity/contraindication to study drugs. 2.Patients with coagulation disorders, infection at the site of spinal injection.
3.Patients with severe renal/hepatic/respiratory or cardiac disease.
4.Pregnant patients with hypertensive disorders/in patients where paramedian approach of spinal anaesthesia will be used.
5.Patients with neurological/psychiatric/neuromuscular disorders/spine anomaly.
6.associated medical illness with relative contraindication to spinal anaesthesia.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. correlation between subarachanoid space depth estimation by derived formula and the actual measurement at lumbar region in patients (males, females and pregnant women) undergoing spinal anesthesia."
2.validation of the formulas derived from the previous study by using sensitivity analysis in patients (males, females and pregnant women) undergoing spinal anesthesia. 		 at baseline and immediate after giving spinal anaesthesia  
 
Secondary Outcome  
Outcome  TimePoints 
Derivation of appropriate formula for subarachanoid space depth calculation based on height, weight, BMI and BSA from the data obtained from this study.  within 1 minute of giving spinal anesthesia n 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
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)   12/02/2026 
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="0"
Months="3"
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   Subarachnoid block is a commonly practiced anaesthesia technique for lower abdominal and limb surgeries, including cesarean sections.Performed using an anatomical landmark guided, blind approach, its sucess depends on factors like height weight BMI and BSA.In conditions such as obesity, pregnancy or edema  estimating subaracnoid space depth is crucial to minimize failed attempts and complications. Existing predictive formulas, largely derived from western population, require validation in indians hence this study aims to establish a reliable, population-specific model for accurate SSD estimation.
A prospective observational study will be conducted at hospitals attached to BMCRI form febrauary 2026 to april 2026  to determine skin to subarachnoid space depth in indian adults undergoing spinal anaesthesia and to assess the accuracy of anthropometric data (height, weight,BMI,BSA) will be  collected and actual SSD will be  measured during midline lumbar puncture. Predicted SSDs will be  calculated using existing and newly derived equations to validate populaton- specific accuracy and improve procedural precision and safety.
 
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