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CTRI Number  CTRI/2024/05/067647 [Registered on: 20/05/2024] Trial Registered Prospectively
Last Modified On: 09/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparision of effectiveness between two local anaesthetic drugs in Subarachnoid block for surgeries below the level of Umblicus. 
Scientific Title of Study   A Comparative study to evaluate the clinical efficacy of Subarachnoid block using Hyperbaric Levobupivacine 0.5% Versus Hyperbaric Ropivacaine 0.75% for elective infraumblical surgeries 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Harshini 
Designation  Post Graduate Resident 
Affiliation  Chamarajanagar Institute of Medical Sciences 
Address  Department of Anaesthesiology Chamarajanagar Institute of Medical Sciences Chamarajanagar Yadapura , CHAMARAJANAGAR Chamarajanagar KARNATAKA 571313 India Chamarajanagar KARNATAKA 571313 India
Department of Anaesthesiology Chamarajanagar Institute of Medical Sciences Chamarajanagar Yadapura , CHAMARAJANAGAR Chamarajanagar KARNATAKA 571313 India Chamarajanagar KARNATAKA 571313 India
Chamarajanagar
KARNATAKA
571313
India 
Phone  8668032022  
Fax    
Email  harshiniharshu2396@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Darshan MS 
Designation  Head of the Department 
Affiliation  Chamarajanagar Institute of Medical Sciences 
Address  Department of Anaesthesiology, Chamarajanagar Institute of Medical Sciences Chamarajanagar

Chamarajanagar
KARNATAKA
571313
India 
Phone  9741376797  
Fax    
Email  darshanms_jss@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Harshini 
Designation  Post Graduate Resident 
Affiliation  Chamarajanagar Institute of Medical Sciences 
Address  Department of Anaesthesiology Chamarajanagar Institute of Medical Sciences Chamarajanagar Yadapura , CHAMARAJANAGAR Chamarajanagar KARNATAKA 571313 India Chamarajanagar KARNATAKA 571313 India
Department of Anaesthesiology Chamarajanagar Institute of Medical Sciences Chamarajanagar Yadapura , CHAMARAJANAGAR Chamarajanagar KARNATAKA 571313 India Chamarajanagar KARNATAKA 571313 India
Chamarajanagar
KARNATAKA
571313
India 
Phone  08668032022  
Fax    
Email  harshiniharshu2396@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology Chamarajanagar Institute of Medical Sciences 
 
Primary Sponsor  
Name  Chamarajanagar Institute of Medical Sciences 
Address  Department of Anaesthesiology Chamarajanagar Institute of Medical Sciences 
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 
Dr Harshini  Chamarajanagar Institute of Medical Sciences  Department of Anaesthesiology Chamarajanagar Institute of Medical Sciences Chamarajanagar Yadapura , CHAMARAJANAGAR Chamarajanagar KARNATAKA 571313 India Chamarajanagar KARNATAKA 571313 India
Chamarajanagar
KARNATAKA 		 8668032022

harshiniharshu2396@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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Inj. Levobupivacaine  3ml of 0.5% Inj.Hyperbaric Levobupivacaine given intrathecally for elective infraumblical surgeries and monitored for 2 hours 
Comparator Agent  Inj. Ropivacaine  3ml of 0.75% Inj.Hyperbaric Ropivacaine given intrathecally for elective infraumblical surgeries and monitored for 2 hours 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  -Patient wiiling to give written informed consent
-Patients belonging to American Society of Anaesthesiologist physical status class 1 and 2 of either sex.
- Patient with age group between 18 to 65 years posted for elective infraumblical surgeries.
 
 
ExclusionCriteria 
Details  1.Patients with coagulation disorders or on anticoagulants.
2.Any other contraindications for spinal anaesthesia.
3.Patients with spinal deformity,infection at the site of the procedure.
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate and compare the onset of sensory and motor block characteristics and duration of sensory and motor block among the two study drugs  2 hours 
 
Secondary Outcome  
Outcome  TimePoints 
To study hemodynamic characteristics between the two drugs
To assess the complications/side effects among the drugs. 		 2 hours 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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   Phase 4 
Date of First Enrollment (India)   01/07/2024 
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)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [harshiniharshu2396@gmail.com].

  6. For how long will this data be available start date provided 01-01-2026 and end date provided 01-01-2027?
    Response (Others) -  01/01/2026 to 01/01/2027

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   Subarachnoid block (SAB) is the most widely used anaesthetic technique for infraumblical surgeries providing a faster, reliable onset,with safe and effective sensory and motor blockade. Hyperbaric local anaesthetic solutions are more predictable with reliable intrathecal spread and less interpatient variability.
Hyperbaric Levobupivacaine is preferred because they produce effective sensory and motor block compared to isobaric preparations and has an added advantage of adjusting the level of block. During literature survey,we could find only few direct comparison between hyperbaric Levobupivacaine and Ropivacaine as they are recently introduced.Hence we wanted to evaluate and compare the block characteristics in terms of sensory,motor characteristics and hemodynamic changes and complications if any.
 
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