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CTRI Number  CTRI/2022/03/041152 [Registered on: 16/03/2022] Trial Registered Prospectively
Last Modified On: 22/03/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   comparison of 0.75% Ropivaciane vs 0.5% Bupivacaine in spinal anesthesia in infraumblical surgeries.  
Scientific Title of Study   “Comparative Evaluation of 0.75% Hyperbaric Ropivacaine versus 0.5% Hyperbaric Bupivacaine for Elective Infraumbilical Surgeries : A randomised controlled study.”  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  WASIMUL HODA 
Designation  ASSISTANT PROFESSOR 
Affiliation  RAJENDRA INSTITUTE OF MEDICAL SCIENCES RANCHI 
Address  DEPARTMENT OF ANAESTHESIOLOGY RIMS RANCHI 834009
KALIASTHAN ROAD RANCHI 834001
Ranchi
JHARKHAND
834009
India 
Phone  8797770602  
Fax    
Email  wasu077@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  WASIMUL HODA 
Designation  ASSISTANT PROFESSOR 
Affiliation  RAJENDRA INSTITUTE OF MEDICAL SCIENCES RANCHI 
Address  DEPARTMENT OF ANAESTHESIOLOGY RIMS RANCHI 834009
KALIASTHAN ROAD RANCHI 834001
Ranchi
JHARKHAND
834009
India 
Phone  8797770602  
Fax    
Email  wasu077@gmail.com  
 
Details of Contact Person
Public Query  
Name  WASIMUL HODA 
Designation  ASSISTANT PROFESSOR 
Affiliation  RAJENDRA INSTITUTE OF MEDICAL SCIENCES RANCHI 
Address  DEPARTMENT OF ANAESTHESIOLOGY RIMS RANCHI 834009
KALIASTHAN ROAD RANCHI 834001
Ranchi
JHARKHAND
834009
India 
Phone  8797770602  
Fax    
Email  wasu077@gmail.com  
 
Source of Monetary or Material Support  
DEPARTMENTAL SUPPORT FOR MATERIAL BY DEPARTMENT OF ANAESTHESIA, RAJENDRA INSTITUTE OF MEDICAL SCIENCES RANCHI JHARKHAND 
 
Primary Sponsor  
Name  DEPARTMENT OF ANESTHESIA RAJENDRA INSTITUTE OF MEDICAL SCIENCES RANCHI JHARKHAND 
Address  RIMS, BARIATU 834009 RANCHI JHARKHAND 
Type of Sponsor  Research institution and hospital 
 
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 WASIMUL HODA  DEPARTMENT OF ANESTHESIA, RAJENDRA INSTITUTE OF MEDICAL SCIENCES   DEPARTMENT OF ANESTHESIA, RIMS, BARIATU 834009, RANCHI JHARKHAND
Ranchi
JHARKHAND 		 8797770602

wasu077@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTE ETHICS COMMITTEE, RIMS , RANCHI  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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  0.5% hyperbaric Bupivacaine   patients in group II will receive 3ml of 0.75% hyperbaric Bupivacaine as spinal anesthesia  
Intervention  0.75% hyperbaric Ropivacaine  patients in group I will receive 3ml of 0.75% hyperbaric Ropivacaine as spinal anesthesia  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  American Society of Anaesthesiologists (ASA) physical status 1 and 2
of Age group between 18 - 60 years of age Undergoing elective infraumbilical surgeries.
 
 
ExclusionCriteria 
Details  Patient refusal, Bleeding disorder, Neurological disease, Local skin infection, Allergy to study drugs, Back deformities, Raised intracranial pressure, Patients on anticoagulant or antiplatelet therapy and ASA physical status >2
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
TIME FOR ONSET OF SENSORY BLOCKADE AT (T10) DERMATOME LEVEL, MAXIMUM SENSORY BLOCKADE ACHIEVED, TIME TO COMPLETE MOTOR BLOCKADE, TIME OF REGRESSION OF SENSORY BLOCKADE AND TIME TO REQUIREMENT OF RESCUE ANALGESIA
 		 UPTO 24 HOURS AFTER SURGERY 
 
Secondary Outcome  
Outcome  TimePoints 
Hemodynamic variations in both groups and Any adverse effects of the drugs used will be recorded
 		 till discharge 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   01/04/2022 
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)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   In stage of Manuscript writing 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   0.5% Hyperbaric bupivacaine is the commonly used drug for providing spinal anaesthesia. However, serious toxicities associated with it triggered the development of alternative local anaesthetics. Introduction of commercially prepared 0.75% hyperbaric ropivacaine opens up possibilities of an alternative drug for spinal anaesthesia with less toxic profile while curtailing the issue of possible contamination associated with self preparation of hyperbaric ropivacaine by addition of glucose. Considering the fact, that bupivacaine is cardiotoxic drug, we planned this study effects of 0.75% Ropivacaine versus 0.5 % Bupivacaine in spinal anesthesia in patients undergoing infraumbilical surgeries.  
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