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CTRI Number  CTRI/2018/04/013004 [Registered on: 04/04/2018] Trial Registered Retrospectively
Last Modified On: 25/03/2018
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   Comparison of chloroprocaine 1% and bupivacaine 0.5% for spinal anaesthesia in patients undergoing surgeries of duration less than 1 hour 
Scientific Title of Study   Comparison of intrathecal isobaric chloroprocaine 1% and 0.5% bupivacaine heavy in patients undergoing day care surgeries - A prospective randomised double blind study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Samanvitha K 
Designation  Doctor - Post graduate 
Affiliation  SDM College Of Medical Sciences and Hospital 
Address  Department of Anesthesiology SDM College Of Medical Sciences and Hospital Sattur Dharwad
SDM College Of Medical Sciences and Hospital Sattur Dharwad
Dharwad
KARNATAKA
580009
India 
Phone  8050800275  
Fax    
Email  samsawants@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Imran Sholapur 
Designation  Assistant Professor 
Affiliation  SDM College Of Medical Sciences and Hospital 
Address  Department of Anesthesiology SDM College Of Medical Sciences and Hospital Sattur Dharwad
SDM College Of Medical Sciences and Hospital Sattur Dharwad
Dharwad
KARNATAKA
580009
India 
Phone  9731047204  
Fax    
Email  drimransholapur@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Imran Sholapur 
Designation  Assistant Professor  
Affiliation  SDM College Of Medical Sciences and Hospital 
Address  Department of Anaesthesiology SDM College Of Medical Sciences and Hospital Sattur Dharwad
SDM College Of Medical Sciences and Hospital Sattur Dharwad
Dharwad
KARNATAKA
580009
India 
Phone  9731047204  
Fax    
Email  drimransholapur@gmail.com  
 
Source of Monetary or Material Support  
SDM College Of Medical Sciences and Hospital Sattur Dharwad 
 
Primary Sponsor  
Name  SDM College Of Medical Sciences and Sciences 
Address  SDM College Of Medical Sciences and Sciences Sattur Dharwad- 580009 
Type of Sponsor  Private 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 
SAMANVITHA K  SDM College Of Medical Sciences and Hospital  Ot theatre complex Department of Anaesthesiology
Dharwad
KARNATAKA 		 8050800275

samsawants@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  ASA1/2,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  ISOBARIC CHLOROPROCAINE 1%  Chloroprocaine is a short acting local anaesthetic agent which is reliable and safe to be used in day care surgeries. It is an ester type local anaesthetic agent with shortest duration of action. After spinal administration of preservative free chloroprocaine, the motor blockade lasts for approximately 40 minutes with onset time of 3 to 5 minutes and time for ambulation is 90minutes. This drug is given intrathecal in our study.  
Comparator Agent  0.5 % BUPIVACAINE HYPERBARIC  Bupivacaine is an amide type local anaesthetic agent which has longer duration of action. When it is used intrathecally, the duration of action ranges from 120 - 150 minutes with an onset time of 5 - 10 minutes. The post- operative recovery time for complete regression of motor blockade is more than 4 hours which is relatively longer when compared to that of chloroprocaine.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Patients who are undergoing day care surgeries
2.Age:18-65years
3.ASA physical status I and II
 
 
ExclusionCriteria 
Details  1.Patient refusal
2.Patient of ASAIII and IV
3.Surgeries extending beyond 60minutes
4.Pregnancy and lactation
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Post operative two segment regression time of intrathecal isobaric chloroprocaine 1% and 0.5% bupivacaine hyperbaric  Start of spinal anaesthesia
1 minute
3 minutes
5 minutes
10 minutes
15 minutes
20 minutes
25 minutes
30 minutes
35 minutes
40 minutes
45 minutes
60 minutes
75 minutes

In post anaesthesia care unit :
On arrival
15 minutes
30 minutes
45 minutes
60 minutes
75 minutes
90 minutes
120 minutes 
 
Secondary Outcome  
Outcome  TimePoints 
TO COMPARE HAEMODYNAMIC RESPONSE AND POSTOPERATIVE VOIDING TIME CAUSED BY ADMINISTRATION OF INTRATHECAL CHLOROPROCAINE AND BUPIVACAINE  120 MINUTES 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   01/12/2017 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   not yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Introduction-Spinal anaesthesia is an extensively used and safe technique for lower abdomen and lower limbs.However few properties limits its use for day care surgeries which includes delayed ambulation, urinary retention and persistence of pain after block regression.Chloroprocaine is a short acting local anaesthetic agent which is reliable and safe to be used in day care surgeries.Since day care surgeries are quite popular in present time, we would like to test chloroprocaine as the intrathecal local anaesthetic agent in comparison with that of bupivacaine.
Materials and methods-Patients in inclusion criteria are randomly allocated into group C( Chloroprocaine) and group B( Bupivacaine).Under strict aseptic precautions subarachnoid block will be performed by 26G Quincke spinal needle in the L3-L4/L4-L5 interspace in sitting position .The patients in Group C will be administered 3.5ml of 1% chloroprocaine isobaric. The patients in Group B will be administered 2.8ml of 0.5% bupivacaine heavy. The time at which injection is completed will be considered as zero time of study and all measurements will be recorded from this point.The level of sensory blockade achieved by the end of 5 minutes can be assessed by needle prick method and the time taken to achieve T10 level will be noted down. Motor blockade is assessed by modified Bromage Scale. The time taken to reach modified Bromage 3 will be recorded. Thereafter the patient will be observed for hemodynamic changes every 2.5minutes for the first 15minutes and 5 minutes until the end of surgery and thereafter for every 15minutes till two segment regression of the block is achieved in post anaesthesia care unit.
Study analysis-Data will be analysed by SPSS software.Continuous variables will be calculated using independent sample t test.Categorical variable will be calculated using chi square.A p < 0.05 will be considered significant.
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