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CTRI Number  CTRI/2024/12/077557 [Registered on: 02/12/2024] Trial Registered Prospectively
Last Modified On: 02/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing 2 drugs for spinal anesthesia for caesarean section 
Scientific Title of Study   A Prospective Randomised Comparative Study of 0.5 percent Hyperbaric Levobupivacaine with Fentanyl and 0.5 percent Hyperbaric Bupivacaine with Fentanyl for spinal anesthesia for Caesarean section. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Manisha vaghela 
Designation  2nd year post graduate  
Affiliation  District hospital ballari  
Address  Anesthesiology department, operation theatre, District hospital, near sangam circle, Dr.Rajkumar road, Ballari.

Bellary
KARNATAKA
583101
India 
Phone  9550348751  
Fax    
Email  manishavaghela07@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Mallanna B P 
Designation  Head of department  
Affiliation  District hospital ballari  
Address  Department of Anesthesiology, district hospital ballari, near sangam circle, Dr.Rajkumar road

Bellary
KARNATAKA
583101
India 
Phone  9845652555  
Fax    
Email  drmallanna@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Manisha vaghela 
Designation  2nd year post graduate  
Affiliation  District hospital ballari  
Address  Department of anesthesiology, operation theatre, District hospital, near sangam circle, Dr. Rajkumar road, Ballari

Bellary
KARNATAKA
583101
India 
Phone  9550348751  
Fax    
Email  manishavaghela07@gmail.com  
 
Source of Monetary or Material Support  
Department of anesthesiology, operation theatre, District hospital Ballari ,Karnataka, India.583101 
 
Primary Sponsor  
Name  Dr Manisha Vaghela  
Address  department of anesthesiology, district hospital ballari, near sangam circle,Dr.Rajkumar road, Ballari, Karnataka, India 583101 
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 Manisha Vaghela  District hospital Ballari   Department of anesthesiology, operation theatre , district hospital , near sangam circle, Dr.Rajkumar road
Bellary
KARNATAKA 		 9550348751

manishavaghela07@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAl ETHICS COMMITTEE, VIMS   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O80||Encounter for full-term uncomplicated delivery,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  0.5% hyperbaric Bupivacaine with fentanyl  Study will compare hemodynamic parameters from baseline uptil 1hour after giving spinal anesthesia, using 9mg of 0.5% hyperbaric levobupivacaine with 20 micrograms fentanyl and 9mg 0.5% hyperbaric bupivacaine with 20 micrograms fentanyl during the study period. 
Comparator Agent  0.5% Hyperbaric Levobupivacaine with Fentanyl   9mg 0.5% hyperbaric levobupivacaine will be give for patients undergoing caeserean section under spinal and compared with 0.5%hyperbaric bupivacaine with fentanyl 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  1.Valid informed and written consent
2.Pregnant mothers with height between 145-165 cms.
3.Pregnant mothers with weight between 50-70kgs
4.Singleton pregnancy with term gestation for elective caserean section. 
 
ExclusionCriteria 
Details  1.Patient refusal
2.Short statured mothers
3.Patients belopnging to ASA class-3 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare haemodynamic changes   Baseline, 2min,4min, 6min, 9min,12min,15min, 30min 45min and 60min 
 
Secondary Outcome  
Outcome  TimePoints 
onset, duration, regression of motor & sensory block
request for analgesia
adverse effects. 		 2min after spinal, 5min & post operative motor & sensory regression is noted  
 
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   N/A 
Date of First Enrollment (India)   18/09/2025 
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)   Open to Recruitment 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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 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 - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [manishavaghela07@gmail.com].

  6. For how long will this data be available start date provided 21-09-2024 and end date provided 20-08-2028?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information -  NIL
Brief Summary   A bolus  spinal injection of local anaesthetic drug using a suitable spinal needle - Quincke Babcock 23G, is the most popular used procedure for painless and comfortable casarean section for both patient  and the surgeon.
   Although Bupivacaine is most commonly used local anesthetic agent in obstetric practice, levobupivacaine is gaining popularity that has almost same onset of sensory blockade with shorter motor blockade band more satisfactory haemodynamics and less use of inotropes intraoperatively.
   The current  will compare hyperbaric levobupivacaine with fentanyl and hyperbaric bupivacaine with fentanyl for spinal anesthesia for caesarean section.. to compare haemodynamics as primary outcome.  
 
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