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CTRI Number  CTRI/2025/04/084688 [Registered on: 13/04/2025] Trial Registered Prospectively
Last Modified On: 08/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of levobupivacaine and levobupivacaine with fentanyl for spinal anesthesia in lower belly surgeries 
Scientific Title of Study   Prospective Randomised Comparative Study of Intrathecal Levobupivacaine and Levobupivacaine with Fentanyl in Infraumbilical 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 Juhi Atul Shah 
Designation  Postgraduate 
Affiliation  D Y Patil Hospital 
Address  1st floor , A Block ,Department of anesthesia Ayyappa Temple Rd, Dr D Y Patil Vidyanagar, Sector 5, Nerul, Navi Mumbai, Maharashtra 400706

Thane
MAHARASHTRA
400706
India 
Phone  9004340652  
Fax    
Email  juhiashah20@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rochana Bakhshi 
Designation  Professor 
Affiliation  D Y Patil Hospital 
Address  1st floor , A Block ,Department of anesthesia Ayyappa Temple Rd, Dr D Y Patil Vidyanagar, Sector 5, Nerul, Navi Mumbai, Maharashtra 400706

Thane
MAHARASHTRA
400706
India 
Phone  9323272151  
Fax    
Email  drrochana@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Rochana Bakhshi 
Designation  Professor 
Affiliation  D Y Patil Hospital 
Address  1st floor , A Block ,Department of anesthesia Ayyappa Temple Rd, Dr D Y Patil Vidyanagar, Sector 5, Nerul, Navi Mumbai, Maharashtra 400706


MAHARASHTRA
400706
India 
Phone  9323272151  
Fax    
Email  drrochana@yahoo.com  
 
Source of Monetary or Material Support  
D Y Patil Hospital 
 
Primary Sponsor  
Name  D Y Patil Hospital 
Address  1st floor , A Block ,Department of anesthesia Ayyappa Temple Rd, Dr D Y Patil Vidyanagar, Sector 5, Nerul, Navi Mumbai, Maharashtra 400706 
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 
DrJuhi Atul Shah  D Y Patil Hospital  1st floor , A Block ,Department of anesthesia Ayyappa Temple Rd, Dr D Y Patil Vidyanagar, Sector 5, Nerul, Navi Mumbai, Maharashtra 400706
Thane
MAHARASHTRA 		 09004340652

juhiashah20@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (IEC) for Biomedical and Health Research  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  Intrathecal Administration of Levobupivacaine 0.5% hyperbaric with Fentanyl  Dose : 22.5mg (3ml) Hyperbaric Levobupivacaine + 25micrograms (0.2ml) Fentanyl Route : Intrathecal Duration : bolus over 10seconds Frequency : single dose 
Intervention  Intrathecal Levobupivacaine 0.75% Hyperbaric  Dose : 22.5mg (3ml) Route: Intrathecal Duration : Bolus over 10 seconds Frequency : single dose  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  All patient giving consent undergoing infraumbilical surgeries

ASA grade I,II
 
 
ExclusionCriteria 
Details  Patients known or suspected to have allergy for study drug.

Patients with any infection at the site of injection

Pregnant patients
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
The primary objectives is to compare the onset and duration of sensory and motor block in subarachinoid block given with levobupivacaine versus levobupivacaine with fentanyl  baseline , after intrathecal administration of drug at 2 mins , 4 mins, 6mins,8mins,10mins,12mins,14mins,16mins,18mins,20mins and 30mins 
 
Secondary Outcome  
Outcome  TimePoints 
Hemodynamic changes between two groups including hear rate , blood pressure and mean arterial pressure  baseline , after induction at 2 mins , 4 mins, 6mins,8mins,10mins,12mins,14mins,16mins,18mins,20mins and 30mins 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   28/04/2025 
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)  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 - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  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 - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [juhiashah20@gmail.com].

  6. For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
    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   Spinal anaesthesia is the most commonly used technique for infraumbilical surgeries because of its unmatchable reliability, cost effectiveness, effective analgesia, muscle relaxation and prolonged postoperative analgesia.. Levobupivacaine has been widely used in ambulatory surgeries after the development of low dose spinal anaesthesia technique. To improve the block characteristics of intrathecally administered low dose local anaesthetics, addition of adjuvant is must. Intrathecal opioids enhance sensory block without prolonging motor and sympathetic block. Among them, Fentanyl has rapid onset of action, binds strongly to plasma proteins and potentiates the afferent sensory blockade thus facilitates reduction in the dose of local anesthetics.

 The aim of the present study is to evaluate the safety and efficacy of equal doses of levobupivacaine plain and levobupivacaine plus fentanyl  with respect to onset and duration of sensory and motor block, postoperative analgesia, hemodynamic parameters and side effects and complications in spinal anesthesia.

 

 
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