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CTRI Number  CTRI/2021/01/030255 [Registered on: 05/01/2021] Trial Registered Prospectively
Last Modified On: 04/01/2021
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Study on spinal anaesthesia failures in caesarean operation 
Scientific Title of Study   A prospective observational analysis of spinal anaesthesia failures in caesarean section 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  suvarna kaniyil 
Designation  additional professor 
Affiliation  government medical college- Kozhikode, Kerala, India 
Address  Department of anaesthesia, Government medical college-Kozhikode, Kerala, India

Kannur
KERALA
673008
India 
Phone  9447638221  
Fax    
Email  suvarnakaniyil@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  suvarna kaniyil 
Designation  additional professor 
Affiliation  government medical college- Kozhikode, Kerala, India 
Address  Department of anaesthesia, Government medical college-Kozhikode, Kerala, India

Kannur
KERALA
673008
India 
Phone  9447638221  
Fax    
Email  suvarnakaniyil@gmail.com  
 
Details of Contact Person
Public Query
 
Name  suvarna kaniyil 
Designation  additional professor 
Affiliation  government medical college- Kozhikode, Kerala, India 
Address  Department of anaesthesia, Government medical college-Kozhikode, Kerala, India

Kannur
KERALA
673008
India 
Phone  9447638221  
Fax    
Email  suvarnakaniyil@gmail.com  
 
Source of Monetary or Material Support  
Department of anaesthesia, Government medical college-Kozhikode, Kerala, India 
 
Primary Sponsor  
Name  Dr Suvarna Kaniyil 
Address  Department of anaesthesia, government medical college-Kozhikode, Kerala, India 
Type of Sponsor  Other [Primary investigator. No funding required as this is only an observational study] 
 
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 SuvarnaK  Operation theatre,IMCH  IMCH, Government medical college-Kozhikode
Kozhikode
KERALA 
9447638221

suvarnakaniyil@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee, Government medical college Kozhikode  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Female 
Details  All pregnant patients coming for emergency and elective caesarean sections during the study period 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Failure rate in regional anesthesia among patients undergoing caesarean sections.  From 20 minutes after giving regional anesthesia to completion of surgery 
 
Secondary Outcome  
Outcome  TimePoints 
1.Managent of failed regional anaesthesia cases.
2.Factors associated with failure 
Intraoperative period 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
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)   11/01/2021 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Objectives:

                     Objectives of this study are to observe the anaesthetic practices for CS to find out the regional anaesthesia failure rate and subsequent management of it. All possible risk factors contributed to failure will also be looked for.

Materials and methods:

                       This prospective observational study will be conducted at Govt medical college, Kozhikode from January 2021 to Jun 2021.Observetios and data collection will be done by the junior resident posted in obstetric OT. Anaesthetic practice in all emergency and elective CS in which spinal anaesthesia was given will be observed to find out the failure rate of spinal anaesthesia and subsequent management of such cases. All cases in which satisfactory analgesia (T6 dermatomal sensory analgesia) is not attained in 20 minutes of lumbar puncture, patient complained of any discomfort or pain during surgery or the duration of spinal anaesthesia was inadequate (< 2hrs) are considered as failed spinal anaesthesia.  The subsequent management of these failed spinal anaesthesia cases will be observed. The data will be collected by a junior resident posted in obstetric OT and the consultant anaesthesia provider of that theatre will be unaware of the study. The demographic details of parturients, indications and duration of CS, technical details of RA, the rate of GA conversion, repeat spinal, supplemental analgesia/ sedation and any complications will be noted. Any contributing factors for failure will be looked for.

 

 
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