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CTRI Number  CTRI/2019/02/017393 [Registered on: 01/02/2019] Trial Registered Prospectively
Last Modified On: 01/02/2019
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   Comparision between Ropivacaine 0.75% with Fentanyl verses Chlorprocaine 1% with fentanyl in caesarean section.  
Scientific Title of Study   A COMPARATIVE STUDY OF INTRATHECAL ISOBARIC ROPIVACAINE 0.75% WITH FENTANYL VERSUS ISOBARIC 2 -CHLOROPROCAINE 1% WITH FENTANYL IN PATIENTS UNDERGOING LOWER SEGMENT CAESAREAN SECTION 
Trial Acronym  CS 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Pratixit vyas 
Designation  Postgraduate student 
Affiliation  JLN medical college ajmer 
Address  Department of anaesthesiology,JLN medical college, Ajmer

Ajmer
RAJASTHAN
305001
India 
Phone  9660922164  
Fax    
Email  vijetapanchu@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrPooja Mathur 
Designation  Associate professor and guide 
Affiliation  JLN medical college ajmer 
Address  Department of anaesthesiology,JLN medical college, Ajmer

Ajmer
RAJASTHAN
305001
India 
Phone  9414003933  
Fax    
Email  drpoojarawat@gmail.com  
 
Details of Contact Person
Public Query  
Name  DrPooja Mathur 
Designation  Associate professor and guide 
Affiliation  JLN medical college ajmer 
Address  Department of anaesthesiology,JLN medical college, Ajmer

Ajmer
RAJASTHAN
305001
India 
Phone  9414003933  
Fax    
Email  drpoojarawat@gmail.com  
 
Source of Monetary or Material Support  
JLN MEDICAL COLLEGE, AJMER 
 
Primary Sponsor  
Name  JLN MEDICAL COLLEGE AJMER 
Address  Department of anaesthesiology, JLN medical college, ajmer 
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 
DrPratixit Vyas  JLN medical college, ajmer  Department of anaesthesiology, jln medical college, ajmer
Ajmer
RAJASTHAN 		 9660922164

vijetapanchu@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee, JLN medical college  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 
Comparator Agent  0.75% ropivacain with fentanyl verses 1% chlorprocaine with fentanyl  To compare duration of analgesia 
Intervention  Spinal block in caeserian section  Time of onset of block and duration of study is around 1 year 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1. Parturients posted for LSCS
2. Age between 18 – 40 years. 
 
ExclusionCriteria 
Details  1. Age < 18 and > 40 years.
2. Patients refusal.
3. Patient sensitive / allergic to local anaesthetic agents.
4. Patients with peripheral sensorineural deficit.
5. Patients on anticoagulants.
6. Infection at the site of lumbar puncture 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
• Onset of sensory blockade
• Duration of analgesia. 		 Time duration of the study is around 1 year 
 
Secondary Outcome  
Outcome  TimePoints 
• Highest level of sensory blockade
• Duration of sensory blockade.
• Onset of motor blockade.
• Duration of motor blockade.
• Quality of motor block
• Two segment regression.
• Effect on hemodynamic parameters.
• Neonatal outcome.
• Complications like nausea, vomiting, pruritus, respiratory distress, sedation, bradycardia (50bpm), hypotension (decrease in SBP30% baseline or 100mm Hg 		 Time duration of the study is around 1 year 
 
Target Sample Size   Total Sample Size="110"
Sample Size from India="110" 
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)   04/02/2019 
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   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

In this study, we will compare the efficacy of intrathecal isobaric ropivacaine 0.75% (22.5mg) with fentanyl (25mcg) versus isobaric 2-chloroprocaine 1 %(30mg) with fentanyl (25mcg) in patients undergoing lower segment caesarean section.

                                                                               

PRIMARY OBJECTIVE:

 

·        Onset of sensory blockade

·        Duration of analgesia.

 

SECONDARY OBJECTIVES:

 

·        Highest level of sensory blockade

·        Duration of sensory blockade.

·        Onset of motor blockade.

·        Duration of motor blockade.

·        Quality of motor block

·        Two segment regression.

·        Effect on hemodynamic parameters.

·        Neonatal outcome.

·        Complications like nausea, vomiting, pruritus, respiratory distress, sedation, bradycardia (<50bpm), hypotension (decrease in SBP>30% baseline or <100mm Hg

 
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