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CTRI Number  CTRI/2026/01/100514 [Registered on: 08/01/2026] Trial Registered Prospectively
Last Modified On: 07/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study comparing the incidence of post dural puncture headache in spinal anesthesia with both landmark technique and the ultrasound guided technique in pregnant women undergoing cesarean section.  
Scientific Title of Study   Comparative study of pre- procedural ultrasound   guidance versus the landmark technique for dural puncture on incidence of Post Dural Puncture Headache ( PDPH ) in obese parturients undergoing lower segment cesarean section. A prospective randomized controlled 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  Dr A S MONISHA  
Designation  POSTGRADUATE DEPARTMENT OF ANAESTHESIA  
Affiliation  SDM COLLEGE OF MEDICAL SCIENCES AND HOSPITAL  
Address  312, 1st A A CROSS BEHIND BANK OF INDIA BASAVESHWARANAGAR BANGALORE 560079

Dharwad
KARNATAKA
560079
India 
Phone  7899707924  
Fax    
Email  Monishakumar1899@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr RAVI BHAT 
Designation  ASSOCIATE PROFESSOR DEPARTMENT OF ANAESTHESIOLOGY  
Affiliation  SDM COLLEGE OF MEDICAL SCIENCES AND HOSPITAL  
Address  DEPARTMENT OF ANAESTHESIOLOGY SDMCMSH MANJUSHREE NAGAR SATTUR DHARWAD 570009 SDM COLLEGE OF MEDICAL SCIENCE AND HOSPITAL MANJUSHREE NAGAR,SATTUR,DHARWAD - 570009 Dharwad KARNATAKA 570009 India

Dharwad
KARNATAKA
570009
India 
Phone  9482181582  
Fax    
Email  Kakkodravi@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr RAVI BHAT  
Designation  ASSOCIATE PROFESSOR DEPARTMENT OF ANAESTHESIOLOGY  
Affiliation  SDM COLLEGE OF MEDICAL SCIENCES AND HOSPITAL  
Address  DEPARTMENT OF ANAESTHESIOLOGY SDMCMSH MANJUSHREE NAGAR SATTUR DHARWAD 570009 SDM COLLEGE OF MEDICAL SCIENCE AND HOSPITAL MANJUSHREE NAGAR,SATTUR,DHARWAD - 570009 Dharwad KARNATAKA 570009 India

Dharwad
KARNATAKA
570009
India 
Phone  9482181582  
Fax    
Email  Kakkodravi@yahoo.co.in  
 
Source of Monetary or Material Support  
SDM COLLEGE OF MEDICAL SCIENCE AMD HOSPITAL SATTUR DHARWAD KARNATAKA 580009 
 
Primary Sponsor  
Name  SDM COLLEGE OF MEDICAL SCIENCE 
Address  SDM COLLEGE OF MEDICAL SCIENCES AND HOSPITAL MANJUSHREE NAGAR SATTUR COLONY, DHARWAD,KARNATAKA 580009 
Type of Sponsor  Private 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 
Dr A S Monisha  OT NUMBER 2 , OT NUMBER 3   SDM COLLEGE OF MEDICAL SCIENCES AND HOSPITAL SATTUR DHARWAD 580009
Dharwad
KARNATAKA 		 7899707924

Monishakumar1899@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The IEC-SDM COLLEGE OF MEDICAL SCIENCES AND HOSPITAL   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 1||Obstetrics,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  PATIENTS UNDERGOING CESAREAN SECTION UNDER SPINAL ANAESTHESIA
PATIENT WILLING TO PARTICIPATE IN THE STUDY
ASA GRADE 2
BMI 25 to 30 kg per meter square  
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To access the incidence of PDPH in obese parturients undergoing c- section in both the ultrasound guided technique and the landmark technique.
  		 PDPH is assessed one post operative day 1till postoperative day 5 or till the patient is discharged  
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="116"
Sample Size from India="116" 
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)   22/01/2026 
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="1"
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 - NO
Brief Summary   This study is a prospective randomized controlled trial comparing two methods of giving spinal anaesthesia , the traditional landmark technique and the ultrasound-guided technique. Patients undergoing surgery will be randomly divided into two groups. In Group A, spinal anaesthesia will be given using the landmark method by feeling the spine bones. In Group B, an ultrasound scan will be done before the procedure to identify the exact spinal level and mark the point for needle insertion. The study will assess the number of needle pricks and redirections, patient satisfaction using a Likert scale, and the occurrence of complications like post-dural puncture headache (PDPH). All patients will be followed for up to five days after the procedure, and those with PDPH will be treated accordingly. The aim of the study is to determine which method is more accurate, efficient, and comfortable for the patient. 
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