| CTRI Number |
CTRI/2024/05/066900 [Registered on: 07/05/2024] Trial Registered Prospectively |
| Last Modified On: |
06/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Patient Satisfaction about use of Spinal Anaesthesia for Lower Segment Caesarean Section at a Tertiary Care Hospital |
|
Scientific Title of Study
|
Patient Satisfaction about use of Spinal Anaesthesia for Lower Segment Caesarean Section at a Tertiary Care Hospital |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Badugu Saikumar |
| Designation |
Post graduate |
| Affiliation |
K S Hegde Medical Academy |
| Address |
Department of Anaesthesia and Operation Theatre Technology,
K S Hegde Medical Academy , Deralakatte post, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8790954612 |
| Fax |
|
| Email |
saikumardans@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Murali Krishna V |
| Designation |
Senior resident |
| Affiliation |
K S Hegde Medical Academy |
| Address |
Department of Anaesthesiology,
Justice K S Hegde Charitable Hospital, Nithyananda Nagar, Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9845196030 |
| Fax |
|
| Email |
muralikrishna@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Badugu Saikumar |
| Designation |
Post graduate |
| Affiliation |
K S Hegde Medical Academy |
| Address |
Department of Anaesthesia and Operation Theatre Technology,
K S Hegde Medical Academy , Deralakatte post, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8790954612 |
| Fax |
|
| Email |
saikumardans@gmail.com |
|
|
Source of Monetary or Material Support
|
| K S Hegde Medical Academy
Deralakatte, Mangaluru - 575018 |
|
|
Primary Sponsor
|
| Name |
K S Hegde Medical Academy |
| Address |
Deralakatte, Mangaluru
Karnataka
India
575018 |
| 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 Murali Krishna V |
Justice K S Hegde Charitable Hospital |
Department of Anaesthesiology and critical Care
Dakshina Kannada
KARNATAKA |
9845196030
muralikrishna@nitte.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O94||Sequelae of complication of pregnancy, childbirth, and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
All pregnant ladies undergoing caesarean section under Spinal Anaesthesia between the age of 19-35 years for maximum of three times |
|
| ExclusionCriteria |
| Details |
Patient refusal for the study, pregnant patients with ASA grade greater than 2, individuals with altered psychological comprehension |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the key role of obstetric anaesthesia caliber in maternal satisfaction following lower segment caesarean section at Justice K S Hegde Charitable Hospital under spinal anaesthesia |
24 hour in postoperative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Assess maternal satisfaction |
From preoperative period to postoperative period |
|
|
Target Sample Size
|
Total Sample Size="115"
Sample Size from India="115"
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)
|
18/05/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
the study is done to ascertain maternal satisfaction levels following an elective or emergency Lower Segment Caesarean Section under spinal anaesthesia at a Tertiary care hospitalSpinal anaesthesia provides rapid , effective , reliable and safe anaesthesia for caesarean section
|