| CTRI Number |
CTRI/2024/04/065943 [Registered on: 18/04/2024] Trial Registered Prospectively |
| Last Modified On: |
21/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To observe two methods (anatomy and ultrasound) in finding the correct space for epidural. |
|
Scientific Title of Study
|
Correlation between anatomical landmark guided and ultrasound guided identification of appropriate thoracic interlaminar space - 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 |
Pranati Kejriwal |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College |
| Address |
Department of Anaesthesiology,
Kasturba Medical College and Kasturba Hospital, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8870038733 |
| Fax |
|
| Email |
Pranati.kejriwal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sushma TK |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College |
| Address |
Department of Anaesthesiology,
Kasturba Medical College and Kasturba Hospital, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
sushma.tk@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Pranati Kejriwal |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College |
| Address |
Department of Anaesthesiology,
Kasturba Medical College and Kasturba Hospital, Manipal
KARNATAKA
576104
India |
| Phone |
8870038733 |
| Fax |
|
| Email |
Pranati.kejriwal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, Kasturba Medical College and Hospital, Manipal, Karnataka, India 576104 |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology |
| Address |
Department of Anaesthesiology,
Kasturba Medical College and Kasturba Hospital, Manipal, Karnataka, India 576104 |
| Type of Sponsor |
Private 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 Pranati Kejriwal |
Department of Anaesthesiology |
OR office, Department of Anaesthesiology, Kasturba Medical College and Hospital, Manipal
Udupi
KARNATAKA |
8870038733
pranati.kejriwal@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, (2) ICD-10 Condition: U07-U07||Provisional assignment of new diseases of uncertain etiology or emergency use, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing elective major abdominal surgery under general anaesthesia scheduled for thoracic epidural insertion |
|
| ExclusionCriteria |
| Details |
Pateint’s refusal
Pregnancy
Emergency surgeries
Contraindication to central neuraxial block |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the identification of appropriate thoracic interlaminar space by use of ultrasound guided and anatomical landmark technique |
baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the difference in interlaminar space identified (in number of levels cranial/caudal) by the ultrasound guided & anatomical landmark techniques |
baseline |
|
|
Target Sample Size
|
Total Sample Size="86"
Sample Size from India="86"
Final Enrollment numbers achieved (Total)= "86"
Final Enrollment numbers achieved (India)="86" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
11/05/2024 |
| Date of Study Completion (India) |
08/05/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| 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
|
Correlation between anatomical, landmarks and ultrasound identification of appropriate interlaminar space in patients scheduled for thoracic epidural insertion undergoing elective major abdominal or thoracic surgeries. A prospective observational cross sectional study. Study duration till June 2025 in Kasturba Medical Hospital, Manipal, Karnataka. |