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CTRI Number  CTRI/2024/07/071395 [Registered on: 26/07/2024] Trial Registered Prospectively
Last Modified On: 27/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study
Modification(s)  
Prospective comparative 
Study Design  Other 
Public Title of Study   A Comparison Of Incidence Of Headaches After Spinal Anesthesia Using Different Spinal Needles 
Scientific Title of Study   A Comparison Of Incidence Of Post Dural Puncture Headache With 25G Quincke’s And 25G Whitacre’s Spinal Needles Following Spinal Anaesthesia 
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 Disney Das 
Designation  Junior Resident 
Affiliation  KS Hegde Medical Academy 
Address  Department of Anesthesiology KS Hegde Medical Academy Derlakatte Mangaluru

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9706429694  
Fax    
Email  Disneydas14@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Anil Shetty 
Designation  Professor 
Affiliation  KS Hegde Medical Academy 
Address  Department of Anesthesiology KS Hegde Medical Academy Derlakatte Mangaluru

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9448012303  
Fax    
Email  shetty.anil10@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Anil Shetty 
Designation  Professor 
Affiliation  KS Hegde Medical Academy 
Address  Department of Anesthesiology KS Hegde Medical Academy Derlakatte Mangaluru

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9448012303  
Fax    
Email  shetty.anil10@gmail.com  
 
Source of Monetary or Material Support  
KS Hegde Medical Academy 
 
Primary Sponsor  
Name  Dr Disney Das 
Address  Department of Anaesthesiology KS Hegde Medical Academy PO Derlakatte Mangaluru 575018 
Type of Sponsor  Other [(Self)] 
 
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 
Dr Disney Das  KS Hegde Medical Academy  Deparment of Anaesthesiology 1st floor KS Hegde Medical Academy PO Derlakatte Managluru - 575018
Dakshina Kannada
KARNATAKA 
9706429694

disneydas14@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KS Hedge Medical Academy Institutional Ethics Commitee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  NIL 
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Intervention  Nil  25G Quincke vs 25G Whitacre needle used in respective groups and post dural puncture headache incidence observed. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patients in the age group of 18 to 65 years undergoing SAB using 25G Quincke
needle or Whitacre needle.
2. ASA PS I and II. 
 
ExclusionCriteria 
Details  Pregnant patients
Intraop General anesthesia administration
Migraine or other neurological or chronic headache patients
BMI more than 35 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Incidence of post dural puncture headache  Daily from post operative period upto post operative day 10. 
 
Secondary Outcome  
Outcome  TimePoints 
Onset   Onset evaluated at Postoperative day 1 to Postoperative day 10. 
Postural effect  Daily at post operative day 1 to post operative day 10. 
Any associated symptoms present?  At post operative day 1 to post operative day 10. 
 
Target Sample Size   Total Sample Size="86"
Sample Size from India="86" 
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)   15/08/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  15/08/2024 
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)   Not Yet Recruiting 
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  
Participants satisfying the inclusion criteria will be evaluated after
obtaining informed written consent.
A thorough pre-anaesthetic evaluation will be done a day prior to surgery. Patient shall be
prepared as per institutional protocol. All patients will be coloaded with 500 ml of
appropriate IV fluid as per standard institutional protocol.
As per the standard procedure, using the midline approach of spinal anaesthesia using
Quincke’s or Whitacre’s spinal needle will be inserted into L3-L4 subarachnoid space and
0.5% of hyperbaric bupivacaine will be injected into the space by a trained anaesthesiologist.
Level of sensory and motor block will be assessed.
All the non-invasive hemodynamic monitoring will be used to record the vitals.
Patient and the observer will be blinded from the type of needle used for spinal anaesthesia.
All patients will be examined on the day of surgery and there after every day for the next ten
days.
The patients will be assessed on post operative day one for signs of PDPH and followed up
till day ten. After day of discharge, will be followed up via telephonic communication. The
following information will be collected from the anaesthesiologist giving the subarachnoid
block about the type of needle used, size, approach, position, number of attempts, ease of
puncture.
After assessing the patients on POD10 about headache with regards to its severity, onset,
effect of posture and associated symptoms like nausea, vomiting, auditory and ocular
symptoms the patients will be allocated into groups Q and W after obtaining information
regarding the procedure from the anaesthesiologist. Accordingly, assessment of more than the
sample size will be done and patients not satisfying the inclusion criteria will be excluded
based on usage of different type and size of needle used. Study will be concluded once the
sample size is reached.
The collected data will be entered into MS Excel followed by the analysis using SPSS
version 22/R Core Team (2023). The comparison of post dural puncture headache following spinal anaesthesia, ease of
puncture and number of attempts between the two groups will be done using Chi Square test/
Fishers exact test/Proportion test. P value<0.05 will be considered statistically significant.
 
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