| CTRI Number |
CTRI/2026/02/103379 [Registered on: 09/02/2026] Trial Registered Prospectively |
| Last Modified On: |
09/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Ultrasound scanning of the spine to measure the epidural space depth and comparing it with the actual epidural space depth during the procedure. |
|
Scientific Title of Study
|
Pre-Procedural lumbar Ultrasound For Estimating Epidural Space Depth and its correlation with Procedural Needle Depth. 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 Navya C R |
| Designation |
Assistant Professor |
| Affiliation |
Rajarajeswari medical college hospital |
| Address |
Rajarajeswari medical college and hospital kambipura mysore road 560074
Bangalore
KARNATAKA
560074
India |
| Phone |
09740060543 |
| Fax |
|
| Email |
crnavya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Navya C R |
| Designation |
Assistant Professor |
| Affiliation |
Rajarajeswari medical college hospital |
| Address |
Rajarajeswari medical college and hospital kambipura mysore road 560074
Bangalore
KARNATAKA
560074
India |
| Phone |
09740060543 |
| Fax |
|
| Email |
crnavya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Navya C R |
| Designation |
Assistant Professor |
| Affiliation |
Rajarajeswari medical college hospital |
| Address |
Rajarajeswari medical college and hospital kambipura mysore road bangalore karnataka
pincode 560074
Bangalore
KARNATAKA
560074
India |
| Phone |
09740060543 |
| Fax |
|
| Email |
crnavya@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Rajarajeswari medical college hospital |
| Address |
Rajarajeswari medical college and hospital kambipura mysore road 560074 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 NAVYA C R |
Rajarajeswari hospital |
Department of anaesthesia 2nd floor Rajarajeswari medical college and hospital kambipura mysore road 560074
Bangalore
KARNATAKA |
9740060543
crnavya@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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N939||Abnormal uterine and vaginal bleeding, unspecified, (2) ICD-10 Condition: N202||Calculus of kidney with calculus of ureter, (3) ICD-10 Condition: M242||Disorder of ligament, (4) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, (5) ICD-10 Condition: K429||Umbilical hernia without obstruction or gangrene, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with body mass index (BMI) more than 25
Those undergoing surgery under epidural or Combined spinal epidural
anaesthesia or General anaesthesia with epidural anaesthesia. |
|
| ExclusionCriteria |
| Details |
Patient refusal
Pregnant patients
Patients with previous spine surgeries
Patients with spine anomalies
Patient with alterted coagulation & bleeding disorders |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
correlation between
the ultrasound depth (UD) and the needle depth (ND) |
ultrasound depth measured on the day of surgery before shifting to OT and needle depth is measured during the epidural insertion time |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The absolute difference between the two values (ND considered to be the “gold
standard”)
The correlation between the BMI & the ND
Number of attempts |
measured during epidural insertion time |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/02/2026 |
| Date of Study Completion (India) |
11/05/2026 |
| Date of First Enrollment (Global) |
20/02/2026 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Its a observational study where epidural depth is measured pre operatively on the day of surgery and comparing it with the actual needle depth while doing the procedure. other parameters like needle depth with BMI and ease of doing the procudure is noted |