| CTRI Number |
CTRI/2021/12/039066 [Registered on: 30/12/2021] Trial Registered Prospectively |
| Last Modified On: |
29/12/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Comparing the accuracy of two palpatory methods for identifying correct space for spinal anaesthesia. |
|
Scientific Title of Study
|
Comparing the accuracy of two palpatory methods for identifying L3-L4 inter-space using ultrasound |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rekha Varghese |
| Designation |
Proffesor |
| Affiliation |
Amrita Institute Of Medical Science |
| Address |
Amrita Institute Of Medical Science
Department of Anesthesia
A block - Tower 6 Floor 1
Ponekkara P O
Kochi
Ernakulam
KERALA
682041
India |
| Phone |
99617723277 |
| Fax |
|
| Email |
drrekhav@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Beegam Shoufi Kunjumon |
| Designation |
P G Resident Anesthesia |
| Affiliation |
Amrita Institute Of Medical Science |
| Address |
Department of Anesthesia,
A block ,
1 st floor - Tower 6
Amrita Institute of Medical Science
Ponnekara
Ernakulam
KERALA
682041
India |
| Phone |
9961772377 |
| Fax |
|
| Email |
beegamshoufi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Beegam Shoufi Kunjumon |
| Designation |
P G Resident Anesthesia |
| Affiliation |
Amrita Institute Of Medical Science |
| Address |
Department of Anesthesia,
A block,
Tower 6- Floor 1,
Amrita Institute of Medical Science,
Ponnekara.
Ernakulam
KERALA
682041
India |
| Phone |
9961772377 |
| Fax |
|
| Email |
beegamshoufi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amrita institute of Medical Science |
|
|
Primary Sponsor
|
| Name |
Amrita Institute Of Medical Science |
| Address |
Ponekkara P O
Kochi
Ernakulam |
| 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 Beegam shoufi kunjumon |
AMRITA INSTITUTE OF MEDICAL SCIENCE |
Department of Anesthesia
A block - Tower 6- Floor1
Ponekkara P O
Kochi
Kerala
682041
Ernakulam
KERALA |
9961772377
beegamshoufi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Ethics Committee of Amrita School of Medicine |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
age above 18 years
BMI 18.5 - 29.9
patients with xray chest and xray KUB |
|
| ExclusionCriteria |
| Details |
spine abnormality
pregnancy
previous spine surgeries
inability to position
patients with chronic back pain
patients with known lumbarisation/sacralisation
patients who are difficult to scan |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparing the accuracy of two different palpatory methods for identifying L3-L4 interspace using ultrasound. |
Before induction. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Whether age ,gender,height,weight,BMI of patient ,experience of clinician has any effect on accuracy of identifying L3-L4 interspace by two methods. |
Before induction. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 4 |
|
Date of First Enrollment (India)
|
05/01/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
05/01/2022 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In this observational study we aim to find out the accuracy of a new method of localising interspinous spaces compared to traditionl method for adminstration of spinal anesthesia |