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CTRI Number  CTRI/2023/08/056895 [Registered on: 24/08/2023] Trial Registered Prospectively
Last Modified On: 03/09/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized Factorial Trial 
Public Title of Study   Comparison of three group of Hyperbaric spinal drugs in Lower abdominal surgeries done in spinal anaesthesia 
Scientific Title of Study   Comparision of 0.75% intrathecal hyperbaric ropivacaine, 0.5% hyperbaric levo-bupivacaine, and 0.5% hyperbaric bupivacaine with fentanyl 25mcg as common adjuvant to all three groups in lower abdominal surgeries 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Brindha 
Designation  Head of the Department 
Affiliation  Vinayaka Missions Kirupananda Variyar Medical College and Hospitals 
Address  Department of Anesthesiology
Chinnaseeragapadi
Salem
TAMIL NADU
636308
India 
Phone  09489221297  
Fax    
Email  princeprem.kumar7@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Arun Kumar 
Designation  Professor 
Affiliation  Vinayaka Missions Kirupananda Variyar Medical College and Hospitals 
Address  Department of Anesthesiology
Chinnaseeragapadi
Salem
TAMIL NADU
636308
India 
Phone  09489221297  
Fax    
Email  cruise2010.mmc@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Dinesh Kumar P 
Designation  M.D.Anaesthesiology 
Affiliation  Vinayaka Missions Kirupananda Variyar Medical College and Hospitals 
Address  Department of Anesthesiology
Chinnaseeragapadi
Salem
TAMIL NADU
636308
India 
Phone  09489221297  
Fax    
Email  dineshswamy95@gmail.com  
 
Source of Monetary or Material Support  
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals Chinnaseeragapadi Ariyanoor Salem 636308 
 
Primary Sponsor  
Name  Department of Anesthesiology 
Address  Vinayaka Missions Kirupananda Variyar Medical College and Hospitals Chinnaseeragapadi Ariyanoor Salem 636308 
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 
Dr Dinesh Kumar  Vinayaka MIssions kirupananda variyar medical college  Department of Anesthesiology Chinnaseeragapadi Ariyanoor 636308
Salem
TAMIL NADU 		 9489221297

dineshswamy95@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Intitutional Ethics Committee, VMKVMCH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Bupivacaine  0.5% Hyperbaric Bupivacaine with fentanyl 25mcg 
Intervention  Comparison of hyperbaric local anaesthetic drugs   Comparision of 0.75% intrathecal hyperbaric ropivacaine, 0.5% hyperbaric bupivacaine, 0.5% hyperbaric levobupivacaine with fentanyl 25mcg as common adjuvant to all three groups in lower abdominal surgeries. 
Comparator Agent  Levo-Bupuvacaine  0.5% Hyperbaric Levo-Bupuvacaine with fentanyl 25mcg 
Comparator Agent  Ropivacaine   0.75% Hyperbaric Ropivacaine with fentanyl 25mcg 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Age more than 18years and less than 60 years
2.ASA Grade I and II patietns
3.Patient giving valid informed consent.
4.Lower Abdominal surgeries taken under only spinal anaesthesia
5. Both male and female patients 
 
ExclusionCriteria 
Details  1.age more than 60 years and less than 18 years
2.ASA grade 3 & 4.
3.Patient refusal.
4.Patients with local infection at puncturing site.
5.Patients with Ischemic and Rheumatic heart diseases.
6.Patients with coagulation defects and patients on anticoagulants.
7.Patients allergic to local anesthetic drugs.
8. Surgeries converted to general anaesthesia. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
Determine the onset of sensory & motor blockade  At Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Duration of motor blockade & oveall hemodynamic changes  After 3 hours 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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 3 
Date of First Enrollment (India)   01/09/2023 
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="0"
Months="6"
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-identification.

  2. What additional supporting information will be shared?
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response (Others) - 

  6. For how long will this data be available start date provided 03-09-2023 and end date provided 18-09-2025?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   Comparision of 0.75% intrathecal hyperbaric ropivacaine, 0.5% hyperbaric levo-bupivacaine, and 0.5% hyperbaric bupivacaine with fentanyl 25mcg as common adjuvant to all three groups in lower abdominal surgeries. Compaing the time of onset of sensory and motor blockade. And also to compare the duration of sensory and motor blockade and the time of first rescue analgesia required by the patient. Toxicity profile of three drugs are also studied in this trail. 
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