| CTRI Number |
CTRI/2024/07/071495 [Registered on: 29/07/2024] Trial Registered Prospectively |
| Last Modified On: |
26/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To check the correlation of grade of lumbar puncture with bedside scoring system in patients scheduled for below umbilical surgeries under spinal anaesthesia at sms medical college, jaipur. |
|
Scientific Title of Study
|
A double blind study to assess the correlation of grade of lumbar puncture with bedside scoring system in patients scheduled for elective infra-umbilical surgeries under spinal anaesthesia at sms medical college, jaipur. |
| 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 Kanchan Chauhan |
| Designation |
Professor, Department of Anesthesiology |
| Affiliation |
Sawai man singh medical college and hospitals |
| Address |
Department of Anesthesiology, Sawai man singh medical college and hospitals, jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
8107872222 |
| Fax |
|
| Email |
kanchan2371@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kanchan Chauhan |
| Designation |
Professor |
| Affiliation |
Sawai man singh medical college and hospitals |
| Address |
Department of Anesthesiology, Sawai man singh medical college and hospitals, Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
8107872222 |
| Fax |
|
| Email |
kanchan2371@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Sneha Mishra |
| Designation |
Postgraduate resident |
| Affiliation |
Sawai man singh medical college and hospitals |
| Address |
Department ofAnesthesiology, Sawai man singh medical college and hospitals, jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9587119505 |
| Fax |
|
| Email |
snehmishra298@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sawai man singh medical college and hospitals, jaipur pincode 302004 rajasthan India |
|
|
Primary Sponsor
|
| Name |
Sawai man singh medical college and hospitals |
| Address |
Department of Anesthesiology, Sawai man singh medical college and hospitals, jaipur
(pincode 302004) rajastha,India |
| 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 Sneha Mishra |
Sawai man singh medical college |
Department of anesthesiology, sawai man singh medical college and hospitals
Jaipur
RAJASTHAN |
9587119505
snehmishra298@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMS Medical College ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z768||Persons encountering health services in other specified circumstances, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients scheduled for elective infra-umbilical surgery under spinal anaesthesia.
2) Patient giving written informed consent.
3) Age: between 20 to 70 years.
4) American Society of Anaesthesiologist (ASA) physical status I and II. |
|
| ExclusionCriteria |
| Details |
1) Patient who is unable to perform forward bend test.
2) Pregnant women. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
Mean of Lumbar Puncture (LP) difficulty score based on 5 patient variables.
|
at baseline
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean of lumbar puncture grading (easy/ moderate/ difficult) |
at 2mins after giving spinal anaesthesia |
|
|
Target Sample Size
|
Total Sample Size="157"
Sample Size from India="157"
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)
|
15/08/2024 |
| 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="8"
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
|
sample of 157 cases is calculated at 95% confidence level and 95% power to verify the expected proportion of 11% difficult lumbar puncture. After that two anaesthesiologists will be assigned for the study. During pre anaesthetic evaluation, patient will be assessed for 5 variables and each scored 0-3 as per proforma by one anaesthesiologist. Another anaesthesiologist with more than 5 years experience, who will not be involved in the pre-anaesthetic assessment of patient variables, will perform the lumbar puncture. |