| CTRI Number |
CTRI/2025/02/080349 [Registered on: 12/02/2025] Trial Registered Prospectively |
| Last Modified On: |
28/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Comparision of incidence of post dural puncture headache between two needes. |
|
Scientific Title of Study
|
A Comparative study of incidence of post dural puncture headache using 25g quicke needle and 25g whitacre spinal 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 |
Dr Vishwajeet Patankar |
| Designation |
Junior resident-Post graduate |
| Affiliation |
Department of Anaesthesiology, ACS medical college and hospital |
| Address |
ACS college and hospital, Dept of Anaesthesiology,
Poonamallee high road, velappanchavadi, chennai
Chennai
TAMIL NADU
600077
India |
| Phone |
9168235790 |
| Fax |
|
| Email |
Vishwajeet393@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrBRavi |
| Designation |
Professor and head of department |
| Affiliation |
Department of Anaethesiology, ACS medical college and hospital |
| Address |
No.678,C.T.H Road, Pattabiram, Dept of Anaesthesiology,
Chennai-72
Chennai
TAMIL NADU
600072
India |
| Phone |
9840123852 |
| Fax |
|
| Email |
ravibala181@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrBRavi |
| Designation |
Professor and head of department |
| Affiliation |
Department of Anaethesiology, ACS medical college and hospital |
| Address |
No.678,C.T.H Road, Pattabiram,Dept of Anaesthesiology,
Chennai-72
Chennai
TAMIL NADU
600072
India |
| Phone |
9840123852 |
| Fax |
|
| Email |
ravibala181@gmail.com |
|
|
Source of Monetary or Material Support
|
| ACS Medical college and hospital pharmacy ( Bd, vygon) |
|
|
Primary Sponsor
|
| Name |
ACS medical college and hospital |
| Address |
Poonamallee high road, velappanchavadi,chennai-600077 |
| 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 Vishwajeet Patankar |
ACS medical college and hospital. |
ACS medical college and hospital,Velappanchavadi ,poonamallee,chennai-600077
Chennai
TAMIL NADU |
9168235790
vishwajeet393@gmail.com |
|
|
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: Z753||Unavailability and inaccessibilityof health-care facilities, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1)All patients undergoing surgery under spinal anaesthesia alone.
2) ASA 1 and ASA 2 patients. |
|
| ExclusionCriteria |
| Details |
1)patient’s refusal.
2)Patients less than 20 years of age.
3)ASA 3 and ASA 4 patients. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)Incidence of headache in the first 48 hours following spinal anaesthesia among 200 patients.
2)Age and sex distribution among patients with PDPH. |
1)Incidence of headache in the first 48 hours following spinal anaesthesia among 200 patients.
2)Age and sex distribution among patients with PDPH. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Age & sex distribution among patients with pdph In the first 48 hours
Age (20years-80years).
|
Age & sex distribution among patients with pdph In the first 48 hours
Age (20years-80years).
|
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
01/03/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [vishwajeet393@gmail.com].
- For how long will this data be available start date provided 22-01-2025 and end date provided 22-01-2027?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Abstract: Post dural puncture headache is one of the most disturbing problem for patients in the post operative period. It occurs after spinal anaesthesia induction due to dural and subarachanoid punture and has a sgnificant effect on the patient’s post operative well being. To compare the incidence of post dural headache in younger and older age groups i.e (20-40), >40.
Introduction: Gender and age are independent risk factors in the development of post dural punture headache. The incidence of pdph, was higher in younger patients as a factor of age. Some data indicate that there is no significant difference in the incidence of pdph in terms of gender. However, other random data suggest that women may have a higer incidence od pdph than males. It is accepted that women have a higher incidence of headaches such as tention types and migraine. There may also be difference in pain sensation processing in women. Women have greater sensitivity to experimentally induced pain. Finally, some data have also suggested that sex hormones may also affect pain sensation due to inconsistencies, we aimed to determine the effect of age and gender on incidence of pdph in our study.
Aim: To compare the incidence of post dural punture headache amongst all people undergoing spinal anaesthesia above the age of 20 in all genders using 25g quincke spinal needle and 25g whitacre spinal needle. |