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CTRI Number  CTRI/2023/04/051935 [Registered on: 25/04/2023] Trial Registered Prospectively
Last Modified On: 24/04/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   "Effectiveness of injection hyperbaric bupivacaine(0.5%) and injection hyperbaric levobupivacaine(0.5%) in caserean section under spinal anaesthesia " 
Scientific Title of Study   Effectiveness of injection hyperbaric bupivacaine(0.5%) and injection hyperbaric levobupivacaine(0.5%) in caserean section under subarachnoid block: double blinded randomised controlled trial.(Dissertation Work)  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Hima kyada 
Designation  1st year resident,anaesthetiology  
Affiliation  Govt. Medical College and sir t hospital Bhavnagar  
Address  Department of anesthesiology, sir t hospital Bhavnagar.
Govt medical College Bhavnagar
Bhavnagar
GUJARAT
364001
India 
Phone  9909151600  
Fax    
Email  kyadahima001@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr lopa trivedi 
Designation  Incharge HOD and associates professor of Department of Anesthesiology  
Affiliation  Govt. Medical College and sir t hospital Bhavnagar  
Address  Department of anesthesiology,govt medical College and sir t hospital Bhavnagar
Govt medical College Bhavnagar
Bhavnagar
GUJARAT
364001
India 
Phone  9428009958  
Fax    
Email  trivedi_lopa@yahoo.in  
 
Details of Contact Person
Public Query  
Name  Dr Hima Kyada 
Designation  1st year resident,Anaesthetiology  
Affiliation  Govt. Medical College and Sir T. hospital Bhavnagar  
Address  Department of anesthesiology Sir T. hospital campus Bhavnagar
Govt medical College Bhavnagar
Bhavnagar
GUJARAT
364001
India 
Phone  9909151600  
Fax    
Email  kyadahima001@gmail.com  
 
Source of Monetary or Material Support  
Govt medical College and sir t hospital Bhavnagar  
 
Primary Sponsor  
Name  Govt medical College and sir t hospital Bhavnagar  
Address  Govt medical College and sir t hospital Bhavnagar  
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 Hima kyada  Sir T general hospital, Bhavnagar   OBGY operation theater, 1st floor, Gopnath meternity home
Bhavnagar
GUJARAT 		 9909151600

kyadahima001@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The ethics committee Government Medical College Bhavnagar   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  pregnant women 
Patients  (1) ICD-10 Condition: O998||Other specified diseases and conditions complicating pregnancy, childbirth and the puerperium,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  hyperbaric levobupivacaine  long acting pure s enantiomer Inj.hyperbaric levobupivacaine 0.5% 2.2 cc given in L3-L4 intervetibral space in subarachnoid space 
Comparator Agent  Inj hyperbaric bupivacaine   long acting pure s enantiomer Inj.hyperbaric bupivacaine 0.5% 2.2 cc given in L3-L4 intervetibral space in subarachnoid space 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Patient undergoing caserean section under subarachnoid block
Age 18 to 40 year
ASA grade 1/2/3 
 
ExclusionCriteria 
Details  Pr having history to study drugs 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Better hemodynamic stability of injection hyperbaric levobupivacaine , early recovery of sensory and motor sensation   During intra op, and till sensory motor recovery, 4hr after lscs 
 
Secondary Outcome  
Outcome  TimePoints 
early recovery of sensory and motor block  At 1h, 2hr, 3 hr, 4hr 
Early recovery of sensory and motor sensation   From onset of effect  
 
Target Sample Size   Total Sample Size="66"
Sample Size from India="66" 
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)   26/04/2023 
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)  Not Yet Recruiting 
Publication Details   not applicable 
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-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

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

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [kyadahima001@gmail.com ].

  6. For how long will this data be available start date provided 15-05-2024 and end date provided 16-11-2023?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIl
Brief Summary  

•   Subarachnoid block is the most commonly used technique for cesarean delivery due to following advantages compared to general anaesthesia[1].

-It is easily performed and provides a rapid onset of sensory and motor block.

- It has good muscle relaxion property with added advantagelike preventing airway manipulation, pressor response from intubation, sore throat, excessive sedation.

- It also help to early establishment of mother baby bond.

 

•   Till date racemic mixture Bupivacaine is most commonly used drug for caserean section but with introduction of newer local anaesthetics which are purely S-enantiomer like Ropivacaine and Levobupivacaine which are having minimal side effect (less cardiotoxic and less neurotoxic), these can be use with increased safety[2].

•   Levobupivacaine is a long-acting amino amide belongs to family n-alkyl substitute Pipecoloxylidide[4].

 
 
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