| CTRI Number |
CTRI/2024/08/072749 [Registered on: 20/08/2024] Trial Registered Prospectively |
| Last Modified On: |
14/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
"Comparison of Post-Dural Puncture Headache in Elective C-Sections with 25G Quincke Needle" |
|
Scientific Title of Study
|
To compare the incidence and severity of PDPH in elective cesarean sections using 25G Quincke 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 |
Renuka Patond |
| Designation |
Junior Resident |
| Affiliation |
Datta Meghe Institute Of Higher Education & Research |
| Address |
Department of Anesthesiology, Acharya Vinoba Bhave Rural Hospital, DMIHER Sawangi, India .
Wardha
MAHARASHTRA
442001
India |
| Phone |
9623232393 |
| Fax |
|
| Email |
renukapatond77.rp@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Renuka Patond |
| Designation |
Junior Resident |
| Affiliation |
Datta Meghe Institute Of Higher Education & Research |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY,ACHARYA VINOBA BHAVE RURAL HOSPITAL,DMIHER, SAWANGI,INDIA.
Wardha
MAHARASHTRA
442001
India |
| Phone |
9623232393 |
| Fax |
|
| Email |
renukapatond77.rp@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Renuka Patond |
| Designation |
Junior Resident |
| Affiliation |
Datta Meghe Institute Of Higher Education & Research |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY,ACHARYA VINOBA BHAVE RURAL HOSPITAL,DMIHER, SAWANGI,INDIA.
Wardha
MAHARASHTRA
442001
India |
| Phone |
9623232393 |
| Fax |
|
| Email |
renukapatond77.rp@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute OF higher Education and Research,Sawangi,442001,India. |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute Of Higher Education and Research |
| Address |
Datta Meghe Institute Of Higher Education and Research,DMIHER, Sawangi,INDIA. |
| 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 |
| RENUKA PATOND |
DATTA MEGHE INSTITUTE OF HIGHER EDUCATION AND RESEARCH |
WARDHA,SAWANGI.
Wardha
MAHARASHTRA |
9623232393
renukapatond77.rp@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DATTA MEGHE INSTITUTE OF HIGHER EDUCATION AND RESEARCH INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P00-P96||Certain conditions originating in the perinatal period, (2) ICD-10 Condition: O60-O77||Complications of labor and delivery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
25 Gauge (25G) Quincke Needle |
The 25-gauge Quincke needle, with a diameter of 0.5 to 0.6 millimeters, has a sharp beveled tip for smooth tissue penetration, making it ideal for procedures requiring a smaller puncture site, like spinal anesthesia and lumbar punctures. Its precise markings allow accurate insertion depth, ensuring safe and effective CSF collection or anesthesia administration. |
| Intervention |
27 Gauge (27G) Quincke Needle: |
The 27-gauge Quincke needle, with a diameter of 0.4 to 0.5 millimeters, is a finer option with a sharp beveled tip, ideal for delicate procedures like spinal anesthesia in pediatric patients or adults needing minimal trauma. Its narrow size allows precision while maintaining strength and rigidity, with depth markings ensuring accurate placement for anesthesia or CSF sampling. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
ASA grade 1&2.
Primigravida posted for elective caesarean section, with a gestational age above 34 weeks,
Patient with single uncomplicated pregnancy,
Age between 20-35years.
Weighing 40-90kg
|
|
| ExclusionCriteria |
| Details |
Patient who don’t give concent.
Patient with spinal abnormalities.
Patient hypertensive disorder of pregnancy.
Soft tissue infection at the needle entry site.
Patient with coagulation disorder.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the incidence and severity of PDPH in elective cesarean sections using 25G Quincke spinal needle-[Spinal Needle] |
Post assessment will be evaluated on same day after procedure, day1 ,day2, day3 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| onset of PDPH |
Up to three days |
|
|
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/ Phase 4 |
|
Date of First Enrollment (India)
|
15/09/2024 |
| 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="2"
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 is a protocol of planning of the study title " To compare the incidence and severity of PDPH in elective cesarean sections using 25G Quincke and 27 G Quincke spinal needle."that will be conducted only after CTRI registration. |