| CTRI Number |
CTRI/2025/04/084527 [Registered on: 09/04/2025] Trial Registered Prospectively |
| Last Modified On: |
08/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Comparative study |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparation of post dural puncture headache with 25G Quincke needle and 25G Whitacre needle |
|
Scientific Title of Study
|
Comparation of post dural puncture headache with 25G Quincke needle and 25G Whitacre needle |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
R PAVITHRA |
| Designation |
Post Graduate |
| Affiliation |
Sri devaraj urs academy of higher education and research |
| Address |
PG resident womens hostel,Sri devaraj urs medical college,Tamaka ,Kolar
D:NO : 22-1098,sbi colony,3rd street,k.r palli,chittoor 517001
Kolar
KARNATAKA
563103
India |
| Phone |
8374147112 |
| Fax |
|
| Email |
pavithra131997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
K DINESH |
| Designation |
Professor of Anaesthesiology |
| Affiliation |
Sri Devaraj Urs Medical College |
| Address |
Sri Devaraj Urs Medical College,Tamaka,kolar
Sri Devaraj Urs academy of higher education and research
Kolar
KARNATAKA
563103
India |
| Phone |
9880463098 |
| Fax |
|
| Email |
drdini2233@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
K DINESH |
| Designation |
Professor of Anaesthesiology |
| Affiliation |
Sri Devaraj Urs Medical College |
| Address |
Sri Devaraj Urs Medical College,Tamaka,kolar
Sri Devaraj Urs academy of higher education and research
Kolar
KARNATAKA
563103
India |
| Phone |
9880463098 |
| Fax |
|
| Email |
drdini2233@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Devaraj Urs Medical College |
|
|
Primary Sponsor
|
| Name |
R PAVITHRA |
| Address |
Sri Devaraj Urs Medical College |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| R PAVITHRA |
Sri Devaraj Urs Medical College |
Tamaka kolar
Kolar
KARNATAKA |
8374147112
pavithra131997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Central ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patients undergoing surgeries under spinal anesthesia |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Comparison of post dural puncture headache with 25G Quincke and 25G whitacre needle |
To assess the severity of headache with both needles |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing surgeries under spinal anesthesia |
|
| ExclusionCriteria |
| Details |
Patients with ASA 3 and 4 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the incidence of post dural puncture headache with 25G Quincke needle and 25G whitacre needle |
To compare the incidence of post dural puncture headache with 25G Quincke needle and 25G whitacre needle |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the severity of PDPH with 25G Quincke needle and 25G whitacre needle |
Within 72hours of surgery |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
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)
|
25/08/2027 |
| 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="0"
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 compare post dural puncture headache with 25G Quincke needle and 25G Whitacre needle |