| CTRI Number |
CTRI/2023/10/059026 [Registered on: 23/10/2023] Trial Registered Prospectively |
| Last Modified On: |
21/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Comparison between usg guided spinal anaesthesia and usg guided pre spinal anesthesia in obese pregnant women |
|
Scientific Title of Study
|
To compare the effectiveness of Real-time Ultrasound guided spinal anesthesia versus pre-procedural Ultrasound guided spinal anesthesia in obese parturients. A randomized control trial |
| 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 Suman S Hiremath |
| Designation |
Post Graduate |
| Affiliation |
BLDE DEEMED TO BE UNIVERSITY SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
| Address |
Department of Anesthesiology
Shri B M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE Vijayapur
Bijapur
KARNATAKA
586103
India |
| Phone |
8892696580 |
| Fax |
|
| Email |
suman.1995.hiremath@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pratibha S D |
| Designation |
Associate Professor |
| Affiliation |
BLDE DEEMED TO BE UNIVERSITY SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
| Address |
Department of Anesthesiology Shri B M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE BLDE DEEMED TO BE UNIVERSITY
Bijapur
KARNATAKA
586103
India |
| Phone |
9113986609 |
| Fax |
|
| Email |
pratibhakaradi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suman S Hiremath |
| Designation |
Post Graduate |
| Affiliation |
BLDE DEEMED TO BE UNIVERSITY SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
| Address |
Department of Anesthesiology Shri B M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE BLDE DEEMED TO BE UNIVERSITY
Bijapur
KARNATAKA
586103
India |
| Phone |
8892696580 |
| Fax |
|
| Email |
suman.1995.hiremath@gmail.com |
|
|
Source of Monetary or Material Support
|
| BLDE DEEMED TO BE UNIVERSITY , Bangarramma Sajjan campus , Solapur road , Bijapur - 586102 |
|
|
Primary Sponsor
|
| Name |
SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
| Address |
SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE BLDE DEEMED TO BE UNIVERSITY SMT BANGARAMMA SAJJAN CAMPUS SOLAPUR ROAD VIJAYAPUR KARNATAKA 586103 |
| 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 Suman S Hiremath |
Shri B M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
BLDE DU’s DEPARTMENT OF ANAESTHESIA , 3rd floor , Blde hospital , bangaramma sajjan campus , Bijapur
Bijapur
KARNATAKA |
8892696580
suman.1995.hiremath@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee BLDE deemed to be university , vijaypura |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Pre procedural ultra sound guided spinal anesthesia |
The landmarks of lumbar space will be identified in the pre operative room with the help of ultrasound machine and with linear probe and 10mg bupivacaine will be given intrathecally |
| Intervention |
Real time ultrasound guided spinal anesthesia |
By using linear probe of ultrasound machine the exact lumbar space where spinal anesthesia will be given is identified in obese partiruents and simultaneously spinal anesthesia will be given intrathecally with 10mg bupivacaine |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Parturients who are for elective cesarean delivery under spinal anesthesia with BMI >30kg/m2
ASA 2-3
Age 18 to 35yrs
>37 weeks of gestation |
|
| ExclusionCriteria |
| Details |
Emergency c section
Contraindications for spinal anesthesia
History of lumbar spinal diseases and lumbar surgery |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Successful spinal anesthesia with respect to time for indentifying the space
|
After 1 minute of giving spinal anaesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Time taken for successful lumbar puncture & analgesia |
90 seconds or more |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
01/11/2023 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
To know Wether real time guided ultrasound spinal anesthesia is better than pre procedural ultra sound guided spinal anesthesia for obese pregnant ladies for faster action of anesthesia.
The study will commence once permission will be obtained from ctri |