| CTRI Number |
CTRI/2025/11/096788 [Registered on: 03/11/2025] Trial Registered Prospectively |
| Last Modified On: |
02/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia
Screening |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Finding out how deep the needle should go for spinal anaesthesia comparing ultrasound scan with a simple body measurement method. |
|
Scientific Title of Study
|
Comparison of ultrasound-guidance with Stockers formula for measurement of depth of subarachnoid
space in patients undergoing spinal anaesthesia. |
| Trial Acronym |
USG |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Safna S S |
| Designation |
PG RESIDENT |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi |
| Address |
Department of anaesthesia , VMMC & Safdarjang Hospital, Ministry of Health & F.W., Govt. of India, Ansari nagar west New Delhi - 110029, India
South
DELHI
110029
India |
| Phone |
8921599630 |
| Fax |
|
| Email |
drsafnaknmp@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepa K Khurana |
| Designation |
Professor |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi |
| Address |
Department of anaesthesia , VMMC & Safdarjang Hospital, Ministry of Health & F.W., Govt. of India, Ansari nagar west New Delhi - 110029, India
South
DELHI
110029
India |
| Phone |
9871813837 |
| Fax |
|
| Email |
drdeepakhurana@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepa K Khurana |
| Designation |
Professor |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi |
| Address |
Department of anaesthesia , VMMC & Safdarjang Hospital, Ministry of Health & F.W., Govt. of India, Ansari nagar west New Delhi - 110029, India
South
DELHI
110029
India |
| Phone |
9871813837 |
| Fax |
|
| Email |
drdeepakhurana@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vardhman Mahavir medical college and Safdarjung hospital |
|
|
Primary Sponsor
|
| Name |
Vardhman Mahavir medical college and Safdarjung hospital |
| Address |
Ansari nagar west , New Delhi , 110029 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Deepa k Khurana |
Vardhman Mahavir Medical College and Safdarjung Hospital |
Department of anaesthesia, ground floor main ot building , room 1 Ansari Nagar, Ring Road, New Delhi – 110029
South
DELHI |
9871813837
drdeepa.khurana@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| VMMC and Safdarjung hospital institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Preprocedural ultrasiund guided skin to subarachnoid space depth estimation |
Each participant undergo three estimations of subarachnoid space depth (SSD)
1. USG Depth Estimation- A pre-procedural ultrasound of the lumbosacral spine using a low-frequency curvilinear probe (2-5 Hz) will be done to measure SSD at the level of the L3-L4 interspace in sitting position
2. Stocker’s formula estimation: SSD will be calculated using the formula: SSD (mm) = 0.5 × weight (kg) + 18
3. Actual depth: Under all aseptic precautions, a subarachnoid block will be performed, and a sterile marker will be used to mark the length of the spinal needle inserted.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
All Patients aged between 18 and 65 years of either gender, ASA1 or 2 status undergoing elective surgeries under spinal anaesthesia |
|
| ExclusionCriteria |
| Details |
1. Patients with known or visible spinal deformities and history of previous spine surgeries.
2. Patients with coagulation abnormalities.
3. Patients with allergic or skin diseases in the spinal area.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To see if ultrasound can be used to predict skin-to-subarachnoid space depth in the adult Indian population
|
Not applicable |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.to see the accuracy of the Stocker formula for actual skin-to-subarachnoid space distance calculation in the adult Indian population
2.To see the number of Sub Arachnoid Block attempts for a successful spinal anaesthesia.
3.To see if Body Surface Area or Body Mass Index has a correlation with Skin to Sub Arachnoid space depth
|
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
13/11/2025 |
| 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="1"
Months="6"
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
|
Eligible patients underwent routine pre-anaesthetic evaluation and were kept fasting .Subarachnoid space depth (SSD) was measured in three ways—by ultrasound at L3–L4, by Stocker’s formula, and by actual needle depth during spinal anaesthesia. All procedures were performed under aseptic precautions in the sitting position using a 25G Quincke spinal needle, by a resident under consultant supervision. Patients requiring a change of interspace were excluded.
|