| CTRI Number |
CTRI/2020/02/023528 [Registered on: 24/02/2020] Trial Registered Prospectively |
| Last Modified On: |
23/02/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
STUDY OF INCIDENCE OF HEADACHE IN OBSTETRIC POPULATION |
|
Scientific Title of Study
|
A Prospective Observational Study To Evaluate The Incidence Of Post Dural Puncture Headache (PDPH) Following Subarachnoid Block In Lower Segment Caesarean Section At Tata Main Hospital, Jamshedpurâ€. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Priyabrata Mohanty |
| Designation |
Dnb Trainee |
| Affiliation |
Tata Main Hospital,Jamshedpur |
| Address |
Department Of Anaesthesiology,Medical Services Division,Main Operation Theatre,2nd floor,831001
Purbi Singhbhum
JHARKHAND
831005
India |
| Phone |
9437602699 |
| Fax |
|
| Email |
mohanty.priyabrata0@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Koshy Varghese |
| Designation |
Consultant,Department of Anaesthesiology |
| Affiliation |
Tata Main Hospital,Jamshedpur |
| Address |
Department Of Anaesthesiology,Medical Services Division,Main Operation Theatre,2nd floor,831001
Purbi Singhbhum
JHARKHAND
831001
India |
| Phone |
8092099753 |
| Fax |
|
| Email |
drkvarghese@tatasteel.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Koshy Varghese |
| Designation |
Consultant,Department of Anaesthesiology |
| Affiliation |
Tata Main Hospital,Jamshedpur |
| Address |
Department Of Anaesthesiology,Medical Services Division,Main Operation Theatre,2nd floor,831001
Purbi Singhbhum
JHARKHAND
831001
India |
| Phone |
8092099753 |
| Fax |
|
| Email |
drkvarghese@tatasteel.com |
|
|
Source of Monetary or Material Support
|
| Tata Main Hospital,Department Of Anaesthesiology,Medical Services Division,Main Operation Theatre,2nd floor,831001 |
|
|
Primary Sponsor
|
| Name |
Tata Main Hospital |
| Address |
Department Of Anaesthesiology,Medical Services Division,Main Operation Theatre,2nd floor,831001 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Tata Main Hospital Jamshedpur |
Department Of Anaesthesiology
Medical Services Division
Main Operation Theatre
2nd floor
pin 831001 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Priyabrata Mohanty |
Tata Main Hospital |
Department Of Anaesthesiology,Medical Services Division,Main Operation Theatre,2nd floor,831001
Purbi Singhbhum
JHARKHAND |
9437602699
916572424031
mohanty.priyabrata0@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE,TATA MAIN HOSPITAL,JAMSHEDPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G971||Other reaction to spinal and lumbar puncture, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Patients undergoing lower segment caesarean section receiving subarachnoid block.
ASA I, II, III.
Both routine and emergency surgeries.
|
|
| ExclusionCriteria |
| Details |
1. Patient below the age for informed consent.
2. Pregnancy induced hypertension.
3. Valvular heart disease and arrhythmias
4. Local site infection at the back.
5. Coagulopathy.
7. Patients having contraindications for neuraxial blockade.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Find the Incidence of PDPH in patients undergoing sub arachnoid block in Lower Segment Caesarean section. |
June 2020 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Needle size 25G quincke and 27 G Quincke needle
2. Number of attempts
3. Operator experience
4. Patient factors Age Weight BMI Gravida
|
june 2020 |
|
|
Target Sample Size
|
Total Sample Size="1305"
Sample Size from India="1305"
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)
|
24/02/2020 |
| 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 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)?
|
|
Brief Summary
|
This observational study is designed to baseline the
incidence and correlate the contributory factors of PDPH after subarachnoid
block in a larger study population at Tata Main Hospital , Jamshedpur; which is
located in the eastern part of India.
|