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CTRI Number  CTRI/2021/12/038991 [Registered on: 28/12/2021] Trial Registered Prospectively
Last Modified On: 22/12/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   comparison of two different methods of injecting drug in spinal anaesthesia in caeserean section patients 
Scientific Title of Study   A Comparative Study Of Fractionated Versus Bolus Dose Injection in Spinal Anesthesia For Patients Undergoing Elective Caesarean Section:a prospective,randomized controlled trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Smitul Dave MD 
Designation  Assistant Professor 
Affiliation  Sri Lakshmi Narayana Institue of Medical Sciences 
Address  Department of anaesthesiology,first floor,Hospital block,Sri lakshmi narayana institute of medical sciences,osodu lake,agaram village,villianur commune,koodapakkam post,pondicherry-605502
Same as address 1
Pondicherry
PONDICHERRY
605502
India 
Phone  9408115792  
Fax    
Email  smitul1511@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Smitul Dave MD 
Designation  Assistant Professor 
Affiliation  Sri Lakshmi Narayana Institue of Medical Sciences 
Address  Department of anaesthesiology,first floor,Hospital block,Sri lakshmi narayana institute of medical sciences,osodu lake,agaram village,villianur commune,koodapakkam post,pondicherry-605502
Same as address 1
Pondicherry
PONDICHERRY
605502
India 
Phone  9408115792  
Fax    
Email  smitul1511@gmail.com  
 
Details of Contact Person
Public Query  
Name  Smitul Dave MD 
Designation  Assistant Professor 
Affiliation  Sri Lakshmi Narayana Institue of Medical Sciences 
Address  Department of anaesthesiology,first floor,Hospital block,Sri lakshmi narayana institute of medical sciences,osodu lake,agaram village,villianur commune,koodapakkam post,pondicherry-605502
Same as address 1
Pondicherry
PONDICHERRY
605502
India 
Phone  9408115792  
Fax    
Email  smitul1511@gmail.com  
 
Source of Monetary or Material Support  
Sri lakshmi narayana institute of medical sciences,osodu lake,agaram village,villianur commune,koodapakkam post,pondicherry-605502 
 
Primary Sponsor  
Name  DrSmitul Dave 
Address  Sri Lakshmi Narayana Institute of Medical Sciences, Osodu lake,agaram village,villinaur commune,koodapakkam post,pondicherry-605502 
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 
Smitul Dave  srilakshmi narayana institute of medical sciences  Department of anaesthesiology,first floor,Hospital block,Sri lakshmi narayana institute of medical sciences,osodu lake,agaram village,villianur commune,koodapakkam post,pondicherry-605502
Pondicherry
PONDICHERRY 		 9408115792

smitul1511@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sri Lakshmi Narayana Institute of Medical Sciences Ethical committee for human studies  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 
Comparator Agent  Conventional single bolus dose spinal injection  Effects of fractionated intrathecal (spinal) injection given into the subarachnoid space will be compared with the conventional single bolus dose(2 ml) technique  
Intervention  Technique of spinal injection  The conventional technique of subarachnoid(spinal) injection is modified into fractionated injection as initial two third, followed by one third of the total dose. The total dose is calculated as per the height of the patient (0.07mg/centimeter) and given throught intrathecal route for providing spinal anaesthesia 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Singleton pregnant patients,ASA grade I and II,
height 140-180 centimeters,with normal range of Body Mass Index,scheduled for elective Caeserean section under spinal anaesthesia 
 
ExclusionCriteria 
Details  Patient refusal,ASA grade III,IV
Height < 140 cm and > 180 cm, weight < 50 kg or >100 kg,
Patients with altered mental status,spine deformities or history of laminectomy,
Patients with preexisting diseases or pregnancy induced hypertension,cardiovascular or cerebrovascular diseases or any contraindications to spinal anaesthesia 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Duration of postoperative analgesia  postoperatively every 30 minutes for the first 2 hours after surgery , then each hourly for next 4 hours 
 
Secondary Outcome  
Outcome  TimePoints 
characteristics of sensory block   6 hours postoperatively 
characteristics of motor block  6 hours postoperatively 
perioperative hemodynamic changes  6 hours postoperatively 
any significant side effects  6 hours postoperatively 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   03/01/2022 
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)  Not Yet Recruiting 
Publication Details   None yet 
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
    Response -  Statistical Analysis Plan

  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 - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [smitul1511@gmail.com].

  6. For how long will this data be available start date provided 10-09-2022 and end date provided 10-09-2025?
    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   This study is a randomized,double blind,parallel group controlled trial  comparing the injection of fractionated dose versus bolus dose of 0.5% hyperbaric bupivacaine given for spinal anaesthesia in patients undergoing elective caeserean section to be conducted at Sri Lakshmi Narayana Institute of Medical Sciences,Pondicherry. The primary outcome measures will be prolonging the postoperative analgesia duration when compared to control group.The secondary outcome measures will be duration of sensory and motor block , the perioperative hemodynamic changes and the side effects observed if any till 6 hours postoperatively.
Fractionated dose provides superior analgesia than bolus dose.
 
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