FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/06/068667 [Registered on: 11/06/2024] Trial Registered Prospectively
Last Modified On: 10/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   Prospective observational study to know incidence of backache and headache in pregnant women undergoing spinal anaesthesia 
Scientific Title of Study   Prospective observational study for incidence of post dural puncture backache and post dural puncture headache in parturients undergoing cesarean delivery under 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  Shravanthi B S 
Designation  Junior resident in department of anaesthesiology and critical care 
Affiliation  Vijaynagar institute of medical sciences,Ballari 
Address  Department of anaesthesiology, Vijayanagar institute of medical sciences, Cantonment , Ballari

Bellary
KARNATAKA
583104
India 
Phone  7022897338  
Fax    
Email  shravanthibs1998@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Srinivasalu D 
Designation  Professor  
Affiliation  Vijaynagar institute of medical sciences, Ballari 
Address  Department of anaesthesiology, Vijayanagar institute of medical sciences, Cantonment , Ballari

Bellary
KARNATAKA
583104
India 
Phone  9845224880  
Fax    
Email  drsrinivasd@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Srinivasalu D 
Designation  Professor  
Affiliation  Vijaynagar institute of medical sciences, Ballari 
Address  Department of anaesthesiology, Vijayanagar institute of medical sciences, Cantonment , Ballari

Bellary
KARNATAKA
583104
India 
Phone  9845224880  
Fax    
Email  drsrinivasd@gmail.com  
 
Source of Monetary or Material Support  
Vijaynagar institute of medical sciences,Cantonment,Ballari,Karnataka,India,583104 
 
Primary Sponsor  
Name  Vijaynagar institute of medical sciencesBallari 
Address  Vijaynagar institute of medical sciences, Cantonment, Ballari, Karnataka, India, 583104 
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 
Dr Shravanthi B S  Vijaynagar institute of medical sciences  Room no.99, Department of Obstetrics and Gynaecology, emergency operation theatre, Ballari
Bellary
KARNATAKA 
7022897338

shravanthibs1998@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Vijaynagar institute of medical sciences,Ballari,Institutional ethics committee, VIMS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  All pergnant women aged 18-45 years undergoing cesarean section under spinal anaesthesia. 
 
ExclusionCriteria 
Details  Patient refusal, Contraindications of spinal anaesthesia like coagulopathy, Infection at the site of puncture, Hemodynamically unstable, Eclampsia, Allergic to local anaesthetics. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To know the incidence of PDPH and PDPB.  Postoperatively the incidence of PDPB and PDPH will be assessed on day 1,3,5 of hospital stay and after 1month, 2month and 3 months after discharge 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary outcomes include factors like : body mass index, pregnancy induced hypertension, poor quality of spinal landmarks, number of skin punctures, needle passes, space level change, size of spinal needle, number of attempts, spinal needle redirections, 1st pass success, second provider, occurrence of bloody tap, number of previous caesarean sections, leakage of CSF   Postoperatively the incidence of PDPB & PDPH will be assessed on day 1,3,5 of hospital stay & after 1month, 2month & 3 months after discharge  
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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)   25/06/2024 
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="1"
Months="0"
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   The study aims at knowing incidence of PDPB and PDPH in 150 parturients undergoing cesarean delivery under spinal anaesthesia.

Study to include pregnant women of age 18 - 45 years undergoing cesarean section under spinal anaesthesia. The number of attempts (skin punctures, needle passes and needle redirections) for successful dural puncture will be noted. Successful identification of the subarachnoid space with one skin puncture and no redirection of the spinal needle will be considered as first pass success, landmark quality (good, poor, none), needle passes, space level change, second provider, bloody tap, intra operative fluid given will be observed. Postoperatively severity of PDPB will be assessed by visual analogue scale (VAS 1‑10) score; 0 = no backache,1–3 = mild backache, 4–7 = moderate backache, >7 = severe backache. And severity of PDPH will be assessed by NRS scale. On the scale, 0 is the absence of headache, 1–3 is mild pain, 4–6 is moderate pain, and 7– 10 is severe pain (disabling; unable to perform daily activities). Postoperatively the incidence of PDPB and incidence of PDPH will be assessed on day 1,3, 5 of hospital stay. In the study phone number of the patient/attender will be taken, going to call them back after 1month, 2month, 3 month to know the well being of the patient, any side effects in particular to PDPB.

Statistical Analysis; The collected data will be entered in the Microsoft Excel 2016 and will be analysed wih IBM SPSS Statistics for Windows, Version 29.0.(Amonk,NY:IBM Corp)

 


 
Close