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CTRI Number  CTRI/2021/01/030779 [Registered on: 27/01/2021] Trial Registered Prospectively
Last Modified On: 26/01/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Prospective observational study of incidence and factors associated with failed spinal anesthesia in obstetric patients. 
Scientific Title of Study   PROSPECTIVE OBSERVATIONAL STUDY OF INCIDENCE AND FACTORS ASSOCIATED WITH FAILED SPINAL ANESTHESIA IN OBSTETRIC PATIENTS. 
Trial Acronym  IFSA 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  JHARNA MILI 
Designation  JUNIOR RESIDENT 
Affiliation  KGMU 
Address  DEPARTMENT OF ANAESTHESIA KGMC
DEPARTMENT OF ANAESTHESIA
Lucknow
UTTAR PRADESH
226003
India 
Phone  9101450238  
Fax    
Email  jharnamili25@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Professor Monica Kohli 
Designation  Professor 
Affiliation  king george medical university 
Address  Department of Anaesthesiology First floor King George Medical University
Department of Anaesthesiology First floor King George Medical University
Lucknow
UTTAR PRADESH
226003
India 
Phone  9839041228  
Fax    
Email  monica_kohli@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  JHARNA MILI 
Designation  JUNIOR RESIDENT 
Affiliation  KGMU  
Address  DEPARTMENT OF ANAESTHESIA
DEPARTMENT OF ANAESTHESIA KGMC
Lucknow
UTTAR PRADESH
226003
India 
Phone  9101450238  
Fax    
Email  jharnamili25@gmail.com  
 
Source of Monetary or Material Support  
KGMU , LUCKNOW 
 
Primary Sponsor  
Name  KGMU 
Address  KGMU 
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 
JHARNA MILI  KING GEORGE MEDICAL UNIVERSITY   QUEEN MARY HOSPITAL, KING GEORGE MEDICAL UNIVERSITY SHAHMINA ROAD, CHOWK
Lucknow
UTTAR PRADESH 
9101450238

jharnamili25@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KING GEORGE MEDICAL UNIVERSITY   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O746||Other complications of spinal andepidural anesthesia during labor and delivery, (2) ICD-10 Condition: O746||Other complications of spinal andepidural anesthesia during labor and delivery,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  1.PATIENT AGED MORE THAN 18YEARS UNDERGOING BOTH ELECTIVE AND EMERGENCY CAESAREAN SECTION IN KING GEORGE MEDICAL UNIVERSITY DURING STUDY PERIOD .
2. AMERICAN SOCIETY OF ANAESTHESIOLOGIST PHYSICAL STATUS CLASSIFICATION I-III. 
 
ExclusionCriteria 
Details  1.PATIENT NOT GIVING CONSENT
2. PATIENTS WITH CONTRAINDICATIONS TO SPINAL ANAESTHESIA
3. PATIENTS WHO ARE UNDERGOING COMBINED SPINAL EPIDURAL ANAESTHESIA  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine the incidence of unsuccessful spinal anesthesia (total or partial ) in obstetric patients.  1.5 YEARS  
 
Secondary Outcome  
Outcome  TimePoints 
1.To determine the factors associated with failed spinal anesthesia
2. To determine the first attempt success (identification of subarachnoid space at first spinal puncture).
3. To determine the incidence of conversion to general anesthesia . 
1.5YEARS  
 
Target Sample Size   Total Sample Size="640"
Sample Size from India="640" 
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)   31/01/2021 
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="2"
Days="2" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Spinal anaesthesia is commonly use to provide regional anaesthesia for elective and emergency caesarean section. apart from excellent anaesthesia , it also avoids the complication of general anaesthesia. It provides rapid onset of anaestheisia, good surgical conditions , a reliable and predictable block and excellent post-operative analgesia. 
Failed spinal anaesthesia is defined as a partial or incomplete spinal block requiring supplemental analgesia or conversion to general anaesthesia. The incidence of failed spinal anaesthesia varies from centre to centre and time to time within the same centre. A retrospective analysis of almost 5000 spinal anaesthesia by Horlocker and colleagues reported 1% failure rate. Parikh KH et al have found that with careful performance of technique , failure rate of as low as 1% is attainable. Sprung Juraj et al concluded that most reliable method of determining the potential for technically difficult block is the examination of patients for quality of landmarks and other obvious factors. the suggestion from these report is that with meticulous attention to detail and appropriate management , most failure of spinal anaesthesia could be prevented . 
This observational study will be conducted to investigate the incidence of failure of spinal anaesthesia , first attempt success, conversion to general anaesthesia and factors associated with failed spinal anaesthesia  in obstetric patients requiring caesarean section in King Georges Medical  University ., Lucknow.
 
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