| CTRI Number |
CTRI/2022/05/042556 [Registered on: 13/05/2022] Trial Registered Prospectively |
| Last Modified On: |
12/05/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
It is the study comparing the conventional landmark technique of spinal anaesthesia with that of ultrasound assisted technique in overweight patients undergoing elective lower abdomen surgeries |
|
Scientific Title of Study
|
Comparison of Real time Ultrasound Guided Spinal Anaesthesia versus conventional landmark guided midline approach in obese patients posted for elective lower abdominal surgeries |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vinuth K Murthy |
| Designation |
Senior Resident |
| Affiliation |
KIMS Hospital, Bangalore |
| Address |
Kempegowda Institute of Medical Sciences and Hospital, K R Road, V V Puram, Bangalore 560004
Bangalore
KARNATAKA
560004
India |
| Phone |
9483949270 |
| Fax |
|
| Email |
vinuthkmurthy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinuth K Murthy |
| Designation |
Senior Resident |
| Affiliation |
KIMS Hospital, Bangalore |
| Address |
Kempegowda Institute of Medical Sciences and Hospital, K R Road, V V Puram, Bangalore 560004
Bangalore
KARNATAKA
560004
India |
| Phone |
9483949270 |
| Fax |
|
| Email |
vinuthkmurthy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vinuth K Murthy |
| Designation |
Senior Resident |
| Affiliation |
KIMS Hospital, Bangalore |
| Address |
Kempegowda Institute of Medical Sciences and Hospital, K R Road, V V Puram, Bangalore 560004
Bangalore
KARNATAKA
560004
India |
| Phone |
9483949270 |
| Fax |
|
| Email |
vinuthkmurthy@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr VINUTH K MURTHY,Department of Anesthesiology,KIMS Hospital, Bengaluru |
|
|
Primary Sponsor
|
| Name |
Dr VINUTH K MURTHY |
| Address |
Senior Resident,
Department of Anesthesiology,
KIMS Hospital, Bengaluru 560004 |
| Type of Sponsor |
Other [myself] |
|
|
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 VINUTH K MURTHY |
Kempegowda institute of medical sciences, Bangalore |
Department of anaesthesia, Kempegowda institute
of medical sciences and hospital,
Bangalore 560004
KARNATAKA
Bangalore
KARNATAKA |
9483949270
vinuthkmurthy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KIMS INSTITUTIONAL ETHICS 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 |
Comparison of Real time Ultrasound Guided Spinal Anaesthesia versus conventional landmark guided midline approach in obese patients posted for elective lower abdominal surgeries |
Comparison of conventional landmark guided midline approach versus Comparison of Real time Ultrasound Guided Spinal Anaesthesia in obese patients posted for elective lower abdominal surgeries |
| Intervention |
using ultrasound guidance |
ultrasound can be used to identify the subarachnoid space in obese patients to reduce the number of attempts taken to get a positive CSF tap |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA physical status 1 and 2 of either sex scheduled for infraumbilical surgeries |
|
| ExclusionCriteria |
| Details |
Gross spinal deformities
History of perineural neuropathy
Sepsis at site of infection
Coagulopathy
History of allergies to LA and opiods
Emergency cases
Pregnant and lactating females |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Comparison of Real time Ultrasound Guided Spinal Anaesthesia versus conventional landmark guided midline approach in obese patients posted for elective lower abdominal surgeries.
The number of attempts taken is the primary objective |
Comparison of Real time Ultrasound Guided Spinal Anaesthesia versus conventional landmark guided midline approach in obese patients posted for elective lower abdominal surgeries.
time taken for successful lumbar puncture is compared.
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| number of passes, time taken for successful lumbar puncture and incidence of complications are taken into consideration |
studies for 6 months |
|
|
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)
|
20/05/2022 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Comparison of Real time Ultrasound Guided Spinal Anaesthesia versus conventional landmark guided midline approach in obese patients posted for elective lower abdominal surgeries |