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CTRI Number  CTRI/2024/02/063152 [Registered on: 26/02/2024] Trial Registered Prospectively
Last Modified On: 25/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Comparison of actual depth of needle insertion in patients receiving spinal anaesthesia with the depth using Stocker’s formula and dpeth using ultrasound. 
Scientific Title of Study   Comparison of the depth of the subarachnoid space using Stocker’s formula and Ultrasonographic measurements with actual depth of needle insertion in patients receiving subarachnoid block at lumbar level: A prospective 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 Amala Gurunath Kudalkar 
Designation  Professor and Head of Department  
Affiliation  Seth GS Medical College and KEM Hospital 
Address  Department of Anaesthesiology Seth GS Medical College and KEM Hospital

Mumbai
MAHARASHTRA
400012
India 
Phone  9869134209  
Fax    
Email  gurukudalkar@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Amala Gurunath Kudalkar 
Designation  Professor and Head of Department  
Affiliation  Seth GS Medical College and KEM Hospital 
Address  Department of Anaesthesiology Seth GS Medical College and KEM Hospital

Mumbai
MAHARASHTRA
400012
India 
Phone  9869134209  
Fax    
Email  gurukudalkar@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Sarika J Chandran 
Designation  Junior Resident 
Affiliation  Seth GS Medical College and KEM Hospital 
Address  Department of Anaesthesiology Room no. 41, first floor,Old building, Seth GS Medical College and KEM Hospital

Mumbai
MAHARASHTRA
400012
India 
Phone  8105202382  
Fax    
Email  sharikajayachandran12@gmail.com  
 
Source of Monetary or Material Support  
Seth G S Medical College and KEM Hospital 
 
Primary Sponsor  
Name  Seth GS Medical College and KEM hsopital 
Address  Acharya Donde Marg, Parel, Mumbai 400012 
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 Amala Gurunath Kudalkar  Seth GS Medical College and KEM Hospital  Department of Anaesthesiology, Room no. 41, Old building
Mumbai
MAHARASHTRA 		 9869134209

gurukudalkar@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee -II, Seth GS Medical College and KEM Hospital  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  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA I, II, or III status
Scheduled for elective surgery under spinal anaesthesia 
 
ExclusionCriteria 
Details  Patient not willing for study
Emergency surgery
All contraindications for Subarachnoid block such as raised intracranial pressure, bleeding diathesis, local
site infection.
Pregnancy
Patients with spinal deformities. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To estimate subarachnoid space depth using USG and Stocker’s formula  Feb 2024- baseline
March 2024- data collection
April 2024- data collection, analysis 
 
Secondary Outcome  
Outcome  TimePoints 
To compare accuracy of USG guided subarachnoid space depth with actual subarachnoid space depth
2. To compare accuracy of subarachnoid space depth using Stocker’s formula with the actual subarachnoid space
depth.
3. Time taken to administer the block using ultrasonography
4. Number of attempts taken
5. Incidence of first attempt success rate
6. Incidence of complications 		 Feb 2024- baseline
March 2024- data collection
April 2024- data collection & analysis 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "65"
Final Enrollment numbers achieved (India)="65" 
Phase of Trial   N/A 
Date of First Enrollment (India)   06/03/2024 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 12/03/2024 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

The primary responsibility of the anaesthesiologist as a clinician is to administer safe anaesthesia and minimise the discomfort and complications associated with administering anaesthesia. 

In this prospective observational study we studied the correlation between subarachnoid space measured by Stocker’s formula and ultrasonography with the actual depth of subarachnoid space to reduce the complications associated with multiple needle punctures, associated trauma, bleeding and neural damage.


65 patients satisfying inclusion criteria were included in the study. Demographic details of all patients were recorded and subarachnoid space depth was calculated using Stocker’s formula. Standard ASA monitors were attached to the patient. A preoperative lumbar ultrasonographic scan was performed in all individuals and the subarachnoid space measured and the site for puncture marked with a sterile dermographic marker. A blinded anaesthesiologist administered subarachnoid block through the puncture site marked previously and safe anaesthesia was administered with standard intraoperative monitoring and ensured safe recovery.

We found that it is possible to estimate subarachnoid space depth using Stocker’s formula and ultrasonography.

It was also found that Stocker’s formula was more accurate than ultrasonography in estimating SSD.

The average time taken for ultrasonography of the spine significantly increased the time to administer the block with an average of 11.14 mins ± 3.3 minutes.

54 out of 65 patients were administered the block in the first attempt and the first attempt success was found to be 83.1%.

In 92.3% cases no complications were encountered and there were no cases of failed blocks.

Hence, we conclude that 

The use of Stocker’s formula is a reliable and easy formula which can be used to estimate the depth of subarachnoid space to reduce the number of complications associated with multiple punctures and trauma. 

Ultrasound can also be used to measure the same with additional benefits of real time assessment of the spine and anatomy but with the drawback of time consumption.



 
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