| CTRI Number |
CTRI/2025/12/099110 [Registered on: 15/12/2025] Trial Registered Prospectively |
| Last Modified On: |
15/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing two spinal needles of same size in prevention of post procedure head ache |
|
Scientific Title of Study
|
A Comparative study of incidence of Post dural puncture headache between 27G Quincke & 27 G whitacre Spinal needles in patients undergoing lower abdominal surgeries |
| 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 M Senthil |
| Designation |
Professor-Anaesthesia |
| Affiliation |
Vinayaka Missions Kirubanandha Variyar Medical College And Hospitals,Salem |
| Address |
Room no-15,Anaesthesia department,Vinayaka Missions Kirubanandha Variyar Medical College And Hospitals,Chinnaseergapadi,
Salem
TAMIL NADU
636308
India
Vinayaka Missions Kirubanandha Variyar Medical College And Hospitals,Chinnaseergapadi,Salem
Salem
TAMIL NADU
636308
India |
| Phone |
9843127550 |
| Fax |
|
| Email |
marappansenthil@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shanu |
| Designation |
Assistant professor-Anaesthesia |
| Affiliation |
Vinayaka Missions Kirubanandha Variyar Medical College And Hospitals,Chinnaseergapadi,Salem |
| Address |
Room no-15,Anaesthesia department,Vinayaka Missions Kirubanandha Variyar Medical College And Hospitals,Chinnaseergapadi,Salem
Vinayaka Missions Kirubanandha Variyar Medical College And Hospitals,Chinnaseergapadi,Salem
Salem
TAMIL NADU
636308
India |
| Phone |
8056603011 |
| Fax |
|
| Email |
shanushanmugasundharam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr V K Shobana |
| Designation |
Post Graduate |
| Affiliation |
Vinayaka Missions Kirubanandha Variyar Medical College And Hospitals,Chinnaseergapadi,Salem |
| Address |
Room no-15,Anaesthesia department,Vinayaka Missions Kirubanandha Variyar Medical College And Hospitals,Chinnaseergapadi,Salem
Vinayaka Missions Kirubanandha Variyar Medical College And Hospitals,Chinnaseergapadi,Salem
Salem
TAMIL NADU
636308
India |
| Phone |
9597957880 |
| Fax |
|
| Email |
dr.shobana14@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vinayaka Missions Kirubanandha Variyar Medical College & Hospitals,Salem |
|
|
Primary Sponsor
|
| Name |
Vinayaka Missions Kirupanandha Variyar Medical College and Hospitals |
| Address |
Chinnaseeragapadi,Salem |
| 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 V K Shobana |
Vinayaka Missions Kirubanandha Variyar Medical College and Hospitals |
Room number 15 Department of Anaesthesia Chinnaseeragapadi Salem
Salem
TAMIL NADU |
9597957880
dr.shobana14@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Vinayaka Missions Kirupananda Variyar Medical College and Hospitals Salem |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
27G Quincke Spinal Needle & 27G Whitacre Spinal Needle |
Spinal anesthesia administered using a 27-gauge Quincke cutting-tip needle & 27G Whitacre Spinal Needle |
| Comparator Agent |
27G Whitacre Spinal Needle |
Spinal anesthesia administered using a 27-gauge Whitacre pencil-point needle. |
| Comparator Agent |
27G Whitacre Spinal Needle |
Spinal anesthesia administered using a 27-gauge Whitacre pencil-point needle. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients scheduled for elective procedures requiring spinal anaesthesia
2.Able to provide informed consent
3.ASA physical status I,II
4.No contraindications to local anaesthetics or coagulopathy |
|
| ExclusionCriteria |
| Details |
1.Patient refusal
2.Age less than 16 years or more than 60 years
3.Patients with known allergies to local anaesthetics
4.Spinal deformities or previous spinal surgeries
5.Infection or sepsis
6.Coagulopathy or bleeding disorders
7.Previous history of PDPH |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the incidence of PDPH between 27G Quincke & 27G Whitacre Spinal Needles |
From 0 point of administering spinal anaesthesia till the patient gets PDPH |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the severity and duration of PDPH |
From 0 point of onset of PDPH till the symptoms gets relieved |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 3 |
|
Date of First Enrollment (India)
|
01/01/2026 |
| 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
|
This study aims to compare how often post-dural puncture headache (PDPH) occurs after spinal anesthesia when two different types of 27-gauge spinal needles are used: the Quincke needle (cutting tip) and the Whitacre needle (pencil-point). Patients undergoing lower abdominal surgeries will be randomly assigned to receive spinal anesthesia with either needle. The incidence and severity of PDPH, along with other related complications, will be monitored after surgery. The study will help determine which needle type is associated with a lower risk of headache and provide guidance for safer spinal anesthesia practice. |