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CTRI Number  CTRI/2024/01/061409 [Registered on: 12/01/2024] Trial Registered Prospectively
Last Modified On: 11/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To compare anaesthesia block produced with the patient lying in two different positions after receiving local anaesthetic injection in the spine for caesarean delivery 
Scientific Title of Study   Comparative evaluation of block characteristics in the supine knee-chest position and supine position in parturients undergoing elective caesarean 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  Anmoldeep Kaur Sran 
Designation  Postgraduate student 
Affiliation  Vardhman Mahavir Medical College and Safdarjung Hospital 
Address  Department of Anaesthesia and Intensive Care Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi

South
DELHI
110029
India 
Phone  8427355499  
Fax    
Email  Anmolkaur15499@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Smita Prakash 
Designation  Professor  
Affiliation  Vardhman Mahavir Medical College and Safdarjung Hospital 
Address  Department of Anaesthesia and Intensive Care Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi

South
DELHI
110029
India 
Phone  9810347125  
Fax    
Email  drsunilprakash@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Smita Prakash 
Designation  Professor  
Affiliation  Vardhman Mahavir Medical College and Safdarjung Hospital 
Address  Department of Anaesthesia and Intensive Care Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi


DELHI
110029
India 
Phone  9810347125  
Fax    
Email  drsunilprakash@gmail.com  
 
Source of Monetary or Material Support  
Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi  
 
Primary Sponsor  
Name  Safdarjung Hospital 
Address  Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi 110029 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
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 Smita Prakash  Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi  Maternity Operation Theatre, Department of Anaesthesia and Intensive Care, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi
South
DELHI 
9810347125

drsunilprakash@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  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, (2) ICD-10 Condition: 1||Obstetrics,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Supine knee-chest position  One minute duration 
Comparator Agent  Supine position  One minute duration 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  American Society of Anesthesiologists physical status II women, with singleton term pregnancy, undergoing elective caesarean delivery under spinal anaesthesia. 
 
ExclusionCriteria 
Details  1. Weight less than 50 kg or more than 100 kg, height < 140 cm and > 170 cm
2. Known allergy to any study medication or any contraindication to spinal anaesthesia
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Onset time of sensory block (measured from intrathecal drug administration till achievement of T6 block height) between supine knee-chest position and supine position in parturients undergoing caesarean delivery  Every 2 min after administration of spinal anaesthesia until there is no further rise in the block level for 4 minutes and at 5 minutes thereafter. 
 
Secondary Outcome  
Outcome  TimePoints 
1.Maximum sensory block height and motor block
2.Incidence of hypotension and bradycardia and requirement of fluid and vasopressor
3.Neonatal APGAR score at 1 min and 5 min
 
Every 2 min after administration of spinal anaesthesia until there is no further rise in the block level for 4 minutes and at 5 minutes thereafter. 
 
Target Sample Size   Total Sample Size="33"
Sample Size from India="33" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   31/01/2024 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  

In pregnant women with category 1 indication for caesarean delivery (immediate threat to life of parturient or foetus) rapid delivery of foetus is necessary. Such patients often receive general anaesthesia, as it is a time saving and a more reliable option compared to the spinal block. There is evidence that the onset of adequate surgical anaesthesia for caesarean delivery can be hastened by placing the patient in the knee-chest position for a minute immediately after performing the spinal anaesthesia in the sitting position. The haemodynamic effect of this technique was safe in the patient population.  There is paucity of literature that compares spinal block characteristics between supine knee-chest and supine positions in parturients undergoing caesarean delivery under spinal anaesthesia. The study hypothesis is that the supine knee-chest position shortens the onset time of sensory block compared with the supine position in parturients undergoing elective caesarean delivery under spinal anaesthesia. Therefore, we are conducting this study to assess the spinal block characteristics between supine knee-chest position and supine position in parturients undergoing elective caesarean delivery.

 
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