| CTRI Number |
CTRI/2025/02/081262 [Registered on: 25/02/2025] Trial Registered Prospectively |
| Last Modified On: |
17/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Screening |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to compare sub arachnoid space depth using ultrasound, stockers formula and measurement of spinal needle in patients posted for elective lower segment cesarean section. |
|
Scientific Title of Study
|
A prospective comparison of sub arachnoid space depth estimation in lumbar region by ultrasound, stockers formula, measurement of spinal needle in patients posted for elective lower segment cesarean section. |
| 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 Sweta |
| Designation |
Associate Professor |
| Affiliation |
LLRM Medical College |
| Address |
Department of anaesthesia LLRM Medical College Meerut Uttar Pradesh
Meerut
UTTAR PRADESH
250004
India |
| Phone |
8750933442 |
| Fax |
|
| Email |
swetaanae@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sweta |
| Designation |
Associate Professor |
| Affiliation |
LLRM Medical College |
| Address |
Department of anaesthesia LLRM Medical College Meerut Uttar Pradesh
UTTAR PRADESH
250004
India |
| Phone |
8750933442 |
| Fax |
|
| Email |
swetaanae@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jheelam Singh |
| Designation |
Senior Resident |
| Affiliation |
LLRM Medical College Meerut |
| Address |
Department of anaesthesia LLRM Medical College Meerut Uttar Pradesh
Meerut
UTTAR PRADESH
250004
India |
| Phone |
6398478017 |
| Fax |
|
| Email |
jheelamsingh7@gmail.com |
|
|
Source of Monetary or Material Support
|
| 2/123, Ground floor, near to IT parking, Department of Anaesthesia
LLRM Medical College
Meerut, Uttar Pradesh India -250004 |
|
|
Primary Sponsor
|
| Name |
LLRM Medical College Department of Anaesthesiology |
| Address |
LLRM Medical College Meerut Uttar Pradesh India250004 |
| 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 Sweta |
LLRM Medical College |
Department of Anaesthesiology LLRM Medical College Meerut
Meerut
UTTAR PRADESH |
8750933442
swetaanae@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office Of The Principal, LLRM MEDICAL COLLEGE, Meerut, Institutional Ethical 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 |
| Comparator Agent |
Spinal needle length by vernier calliper |
Measurement of Subarachnoid space using spinal needle measurement in patients undergoing elective lower segment cesarean section.
Duration is not applicable |
| Comparator Agent |
Stockers formula |
Measurement of subarachnoid space depth using, Stockers Formula
Duration is not applicable |
| Intervention |
Ultrasonography |
Usg based screening of lumbar spine will be done
Duration is not applicable |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Patient undergoing elective lower segment cesarean section |
|
| ExclusionCriteria |
| Details |
1. Refusal to spinal anaesthesia
2. Infection at injection site
3. Coagulopathy
4. History of spinal abnormalities, previous spinal surgery |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate accuracy of stockers formula in estimation of subarachnoid space depth |
At 36,37 weeks period of gestation before giving spinal anaesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Number of attempts required for successful dural puncture |
from the screening of spine ,at 0 minute |
| Number of needle redirections in the same space |
at 0 mins |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
17/03/2025 |
| 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="0"
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
|
It is a prospective randomised study to measure subarachnoid space depth using ultrasound, stocker’s formula in patients undergoing elective lower segment cesarean section with spinal needle measurement. |