| CTRI Number |
CTRI/2023/06/054476 [Registered on: 27/06/2023] Trial Registered Prospectively |
| Last Modified On: |
26/06/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
COMPARATIVE STUDY |
| Study Design |
Other |
|
Public Title of Study
|
Occurance Of Headache After Delivery through operation |
|
Scientific Title of Study
|
Incidence of postdural puncture headache with median and paramedian approach in caesarian section- A Comparative Study |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mohana Krishna Reddy Egabojjireddygari |
| Designation |
Assistant Professor |
| Affiliation |
sri venkateswara medical college |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY
SRI VENKATESWARA MEDICAL COLLEGE
TIRUPATI
ANDHRA PRADESH alipiri road
TIRUPATI
ANDHRA PRADESH
INDIA
Chittoor ANDHRA PRADESH 517507 India |
| Phone |
7013558161 |
| Fax |
|
| Email |
mkreddydoctor@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Mohana Krishna reddy Egabojjireddygari |
| Designation |
Assistant Professor |
| Affiliation |
sri venkateswara medical college |
| Address |
Sri Venkateswara Medical College
Tirupati
alipiri road
TIRUPATI
ANDHRA PRADESH
INDIA
Chittoor ANDHRA PRADESH 517507 India |
| Phone |
7013558161 |
| Fax |
|
| Email |
mkreddydoctorprincipalsvmctpt@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Mohana Krishna Reddy Egabojjireddygari |
| Designation |
Assistant Professor |
| Affiliation |
sri venkateswara medical college |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY
SRI VENKATESWARA MEDICAL COLLEGE
TIRUPATI
alipiri road
TIRUPATI
ANDHRA PRADESH
INDIA
Chittoor ANDHRA PRADESH 517507 India |
| Phone |
7013558161 |
| Fax |
|
| Email |
mkreddydoctor@gmail.com |
|
|
Source of Monetary or Material Support
|
| Governament Maternity Hospital
Affiliated To Sri Venkateswara Medical College
TIRUPATI |
|
|
Primary Sponsor
|
| Name |
Medical Superintendent |
| Address |
Maternity Hospital
Sri Venkateswara Medical College
Tirupati |
| 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 |
| DrMohana Krishna Reddy Egabojjireddygari |
Maternity Hospital |
department of Obstetrics and Gynaecology, Institute for Pregnant Woman Chittoor ANDHRA PRADESH |
7013558161
mkreddydoctor@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 |
| Healthy Human Volunteers |
healthy pregnant woman |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1) ASA PS I and II
2) Aged between 18 to 40 years
3) Elective Cesarean section under Spinal anesthesia
|
|
| ExclusionCriteria |
| Details |
1. Previous history of oxytocin allergy
2. Valvular diseases complicating pregnancy
3. Other cardiac diseases complicating pregnancy
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the incidence of Postdural puncture headache (PDPH) following median & para-median approaches in patients undergoing elective spinal anesthesia for lower segment cesarean section in Governament Maternity hospital, Tirupati |
4 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To record the incidence of adverse effects
To record & treat the incidence of nerve palsies
|
4 |
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
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)
|
15/07/2023 |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan
- 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 [mkreddydoctor@gmail.com].
- For how long will this data be available start date provided 01-12-2023 and end date provided 15-12-2028?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Spinal anaesthesia remains one of the basic techniques
in the arsenal of the modern
anaesthesiologist despite the waxing and waning of its
popularity over the 100 years since its introduction in to clinical
practice.
Spinal anaesthesia is used extensively for lower abdominal
and lower extremity
surgeries because it has distinct
advantages over general
anaesthesia, minimum
physiological disturbance resulting in minimum stress response, optimal operative
conditions, minimal intraoperative blood loss and less postoperative morbidity, it is often
associated with significant adverse effects like hypotension, bradycardia and post dural puncture headache (PDPH).
Ever since its
advent, the spread of popularity of spinal anaesthesia has to some
extent, been checked by the complications of PDPH.
Post dural puncture headache
was first documented by German surgeon
August Bier in 1899. Bier also gained firstâ€hand
experience of the disabling headache related
to dural puncture. Headache and backache are the dominant symptoms that develop after post dural puncture. Ninety
per cent of headaches will occur within 2-3 days
of the procedure.
Headache is the predominant and described as severe,
‘searing and spreading like hot metal1’.The common distribution is over the frontal
and occipital areas radiating to the neck and shoulders. The temporal, vertex and nuchal areas are reported less commonly as the site of discomfort, although neck stiffness may be
present. The pain is exacerbated by head movement, and adoption of the
upright posture, and relieved by lying down.
There are many factors that influence its development:
Age, sex, ambulation, pregnancy,
hydration, needle size and design, bevel direction, number of punctures and approach – median and paramedian.
Though much work has been done on needle size and
design, less information is available on needle approach and its relation to PDPH2,3.
Since prevention is
better than cure, proper selection of the technique can yield
satisfactory and admirable results in a very large proportion of cases and can provide satisfaction to all concerned. |