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CTRI Number  CTRI/2025/03/081511 [Registered on: 03/03/2025] Trial Registered Prospectively
Last Modified On: 03/03/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To Compare effects of Levobupivacaine with Ropivacaine(Isobaric) and Levobupivacaine in abdominal Hysterectomy 
Scientific Title of Study   Study to Compare Effects of Levobupivacaine Heavy with Ropivacaine(Isobaric) and Levobupivacaine Heavy in Patients Posted for Abdominal Hysterectomy(Two Drug Technique) 
Trial Acronym  Nill 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anil Kumar 
Designation  Assistant Professor 
Affiliation  Government Medical College Jalaun(Orai)dical  
Address  Department of Anesthesia, OT Complex, Room Number 5, GMC Jalaun(Orai) Uttar Pradesh
Kalpi Road
Jalaun
UTTAR PRADESH
285001
India 
Phone  9454224498  
Fax    
Email  dranilkumarucr@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sunit Kumar 
Designation  Associate Professor 
Affiliation  Government Medical College Jalaun(Orai) 
Address  Department of Anesthesia and Critical Care, OT complex , Room Number 5. GMC Jalaun( Orai)
Kalpi Road
Jalaun
UTTAR PRADESH
285001
India 
Phone  9532456809  
Fax    
Email  sunit.sachan@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sunit Kumar 
Designation  Associate Professor 
Affiliation  Government Medical College Jalaun(Orai) 
Address  Department of Anesthesia and Critical Care, OT complex, Room Number 5 , GMC Jalaun(Orai)
Kalpi Road

UTTAR PRADESH
285001
India 
Phone  9532456809  
Fax    
Email  sunit.sachan@gmail.com  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  Dr Anil Kumar 
Address  Department of Anesthesia and Critical Care, OT Complex, Room Number 5 , GMC Jalaun(Orai) 
Type of Sponsor  Other [Self] 
 
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 Anil Kumar  Government Medical college, Jalaun(Orai)  Department of Anesthesia and critical care ,room number 5, OT Complex, GMC Jalaun(Orai) 285001 Uttar Pradesh India
Jalaun
UTTAR PRADESH 		 9454224498

dranilkumarucr@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, GMC Jalaun(Orai)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N72||Inflammatory disease of cervix uteri,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  1 Levobupivacaine Heavy 2 ropivacaine Isobaric  1 ml (5mg) hyperbaric levobupivacaine 0.5% and 25 mcg fentanyl at T8-T9, followed by 1.5 ml isobaric ropivacaine in different syringe at same space (Two Drug Technique), once at the time of induction 
Intervention  Levobupivacaine (Heavy)  2.5ml (12.5mg) of hyperbaric levobupivacaine 0.5% and 25 mcg fentanyl at L3-L4 Space Intrathecally, once at time of induction of the case 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  1 Gynecologic indication like Fibroid, Abnormal Uterine Bleeding, Adenomyoma etc.
2 Body weight 50kg to 90 kg
3 Height 150 cm to 170 cm 
 
ExclusionCriteria 
Details  1 ASA IV
2 Emergency
3 Uncontrolled Diabetes and Hypertension
4 Chronic Renal Disease
5 Anemia
6 IHD or other Cardiac Disease 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Hemodynamic Stability  AT Baseline, 6 Hours, 12 Hours 
 
Secondary Outcome  
Outcome  TimePoints 
Need of Rescue Analgesia measured by Verbal Rating Scale   12 hours and 24 hours 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   14/03/2025 
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)   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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

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

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  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 - Proposals should be directed to [dranilkumarucr@gmail.com].

  6. For how long will this data be available start date provided 16-05-2025 and end date provided 21-11-2025?
    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   Multiple steps have been tried to prevent Hypotension during Spinal Anesthesia, In this study we have compare the outcome of Spinal injection  of isobaric Ropivacaine and Hyperbaric Levobupivacaine with Hyperbaric Levobupivacaine  alone , Fentanyl as Adjunctive used in both, comparison  done for the Hemodynamic stability. 
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