| CTRI Number |
CTRI/2022/10/046747 [Registered on: 25/10/2022] Trial Registered Prospectively |
| Last Modified On: |
21/10/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
comparitive |
| Study Design |
Non-randomized, Placebo Controlled Trial |
|
Public Title of Study
|
A observational study to assess the effectiveness of sphenopalatine ganglion block and tb caffiene in treatment of Post dural pucture headache FOLLOWING lower segment ceaserean section |
|
Scientific Title of Study
|
"A COMPARATIVE CLINICAL STUDY TO ASSESS THE EFFECTIVENESS OF SPHENOPALATINE GANGLION BLOCK AND ORAL CAFFEINE IN MANAGEMENT OF POSTDURAL PUNCTURE HEADACHE FOLLOWING LOWER SEGMENT CESAREAN SECTION". |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rajendra kumar |
| Designation |
PG student |
| Affiliation |
gajra raja medical college gwalior |
| Address |
Department of Anaesthesiology Gajra raja medical college gwalior M.P.
Bhopal
Gwalior
MADHYA PRADESH
474009
India |
| Phone |
7999903911 |
| Fax |
|
| Email |
rajen2389.5@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Drpreeti goyal |
| Designation |
Professor |
| Affiliation |
Gajra Raja medical college |
| Address |
Department of Anaesthesiology, Gajra raja medical college gwalior M.P. 474009
Gwalior
MADHYA PRADESH
474009
India |
| Phone |
9424455330 |
| Fax |
|
| Email |
drpreetiravigoyal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rajendra kumar |
| Designation |
PG student |
| Affiliation |
Gajra raja medical college gwalior |
| Address |
Department of anaesthesilogy ,GRMC,Gwalior M.P. 474009
Gwalior
MADHYA PRADESH
474009
India |
| Phone |
|
| Fax |
|
| Email |
rajen2389.5@gmail.com |
|
|
Source of Monetary or Material Support
|
| GAJRA RAJA MEDICAL COLLEGE department of anaesthesiology gwalior madhya predesh |
|
|
Primary Sponsor
|
| Name |
Gajra raja medical college |
| Address |
Gwalior |
| Type of Sponsor |
Government 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 |
| Rajendra Kumar Ahirwar |
Gajra Raja medical college Gwalior MADHYA PRADEWSH |
Jayarogya Hospital Department of anaesthesilogy 1floor gwalior
Gwalior
MADHYA PRADESH |
7999903911
rajen2389.5@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics commtiee,Gajra raja medical college Gwalior |
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 |
TO assess the effectiveness of sphenopalatine ganglion block in managemnet of PDPH |
To compare the effectiveness between sphenopalatine ganglion block and oral caffeine (300mg) in managemnet of PDPH |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Patients who will give consent to participate in study
patients aged between 18 yaear to 50 year female
ASA physical grade 1 and 2 |
|
| ExclusionCriteria |
| Details |
Patients refusal
uncoperative patients
history of facial trauma
coagulopathy or bleeding diathesis |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the efficacy of sphenopalatine ganglion block in management of PDPH
|
24 week
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| TO assess the efficacy of oral caffeine 300 mg in management of PDPH. |
24 week |
| To asess the side effect of sphenopalatine ganglion block |
To assess the side effect of tablet caffeine |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
30/10/2022 |
| 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 Yet Recruiting |
| 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)?
Response - NO
|
|
Brief Summary
|
This study prospective observation randomized study comapartive study to assess the effectiveness of SPG block and tablet caffeine in management of Post diural puncture headache IN lower segment cearean section . post dural puncture headache common problem in patients undergoing lower segment ceasrean section. |