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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  healthy pregnant woman 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
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 
 
Secondary Outcome  
Outcome  TimePoints 
To record the incidence of adverse effects
To record & treat the incidence of nerve palsies
 
 
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
  1. 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).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. 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.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [mkreddydoctor@gmail.com].

  6. 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.

  7. 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 first‐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.

 
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