| CTRI Number |
CTRI/2020/06/025865 [Registered on: 15/06/2020] Trial Registered Prospectively |
| Last Modified On: |
14/06/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Prediction of needle depth from skin to subarachnoid space on the basis of preoperative assessment and other variables. |
|
Scientific Title of Study
|
Prediction from skin to subarachnoid space depth On the basis of preoperative assessment and other variables: an observational study At SMS hospital jaipur during 2019-2021 |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mamta Khandelwal |
| Designation |
Professor |
| Affiliation |
SMS medical college |
| Address |
Department of Anaesthesia second floor
SMS medical college
Jaipur
RAJASTHAN
302004
India |
| Phone |
9929338174 |
| Fax |
|
| Email |
drmamtakhandelwal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mamta Khandelwal |
| Designation |
Professor |
| Affiliation |
SMS medical college |
| Address |
Department of Anaesthesia second floor
SMS medical college
Jaipur
RAJASTHAN
302004
India |
| Phone |
9929338174 |
| Fax |
|
| Email |
drmamtakhandelwal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ekta Tiwari |
| Designation |
Junior resident |
| Affiliation |
SMS medical college |
| Address |
Department of Anaesthesia
SMS medical college
Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
08383029224 |
| Fax |
|
| Email |
etiwari05@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, SMS Medical College, JLN marg, Jaipur (Rajasthan) Pin-
302004 |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology SMS Medical College JLN marg Jaipur Rajasthan Pin |
| Address |
Department of Anaesthesiology SMS Medical College
LN marg, Jaipur (Rajasthan) Pin- 302004 |
| 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 Mamta Khandelwal |
SMS Medical Collegeand Hospital, Jaipur |
Department ofAnaesthesiology,second floor.Dhanwantari bhavan,JiapurJaipurRAJASTHAN
Jaipur
RAJASTHAN |
9929338174
drmamtakhandelwal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMS Medical CollegeEthics Committee,Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: V42||Car occupant injured in collisionwith two- or three-wheeled motor vehicle, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients willing to give written informed consent.
Patients with ASA grade I and II.
Patients undergoing lower limb surgery under spinal anesthesia
|
|
| ExclusionCriteria |
| Details |
Patient allergic to drugs used for spinal anaesthesia.
Patients with bleeding or coagulation disorders.
Patients with spine deformities or local skin infection overlying the lumbar vertebral region.
Psychiatric patients.
Uncooperative patients
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To find the value of observed SSD.
|
Skin to subarachnoid space at the time of spinal anaesthesia will be measured using measuring scale during spinal anaesthesia at baseline and logistic regression would be used to predict depth using independent variables
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Mean value of anthropometric variables.
Mean value of predicted SSD by using different formulas.
Mean difference between the predicted value and observed value of SSD.
|
To determine which formula is closest to the observed depth in study duration at baseline
|
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
21/06/2020 |
| 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
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
In this study we measure skin to subarachnoid space depth in patients undergoing surgery for lower limbs under spinal anaesthesia and compare it with the standard formulas available for measuring the SSD. |