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CTRI Number  CTRI/2025/12/098872 [Registered on: 11/12/2025] Trial Registered Prospectively
Last Modified On: 10/12/2025
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 spinal anesthesia given in the midback versus the lower back using the drug levobupivacaine 
Scientific Title of Study   Comparison of Thoracic segmental spinal anesthesia using Isobaric Levobupivacaine(0.5%) versus Lumbar spinal anesthesia using Hyperbaric Levobupivacaine(0.5%) for paraumbilical and infraumbilical surgery: A Randomized controlled trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
MAMC/IEC/2025/48  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SHAGUN 
Designation  POSTGRADUATE RESIDENT 1ST YEAR 
Affiliation  Maharaja Agrasen Medical College, Agroha 
Address  Department of Anesthesiology and critical care Maharaja Agrasen Medical College, Agroha

Hisar
HARYANA
125047
India 
Phone  8708589823  
Fax    
Email  shagunchahal1301@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  SHAGUN 
Designation  POSTGRADUATE RESIDENT 1ST YEAR 
Affiliation  Maharaja Agrasen Medical College, Agroha 
Address  Maharaja Agrasen Medical College, Agroha

Hisar
HARYANA
125047
India 
Phone  8708589823  
Fax    
Email  shagunchahal1301@gmail.com  
 
Details of Contact Person
Public Query  
Name  SHAGUN 
Designation  POSTGRADUATE RESIDENT 1ST YEAR 
Affiliation  Maharaja Agrasen Medical College, Agroha 
Address  Department of Anesthesiology and critical care Maharaja Agrasen Medical College, Agroha

Hisar
HARYANA
125047
India 
Phone  8708589823  
Fax    
Email  shagunchahal1301@gmail.com  
 
Source of Monetary or Material Support  
Maharaja Agrasen Medical College, Agroha,Hisar 125047 INDIA  
 
Primary Sponsor  
Name  DR SHAGUN 
Address  Maharaja Agrasen Medical College, Agroha 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
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 SHAGUN  Maharaja Agrasen Medical College, Agroha  Department of Anesthesiology and Critical care Maharaja Agrasen Medical College, Agroha
Hisar
HARYANA 		 08708589823

shagunchahal1301@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE FOR HUMAN RESEARCH MAMC AGROHA   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  Lumbar spinal with Hyperbaric Levobupivacaine   Group LS (Lumbar spinal with Hyperbaric Levobupivacaine group): patients will receive 2.5 ml intrathecal injection of Hyperbaric Levobupivacaine (0.5%) and 25µg (0.5ml) of injection Fentanyl total dose of 3ml. 
Intervention  Thoracic segmental spinal with Isobaric Levobupivacaine   Group TS (Thoracic segmental spinal with Isobaric Levobupivacaine group): patients will receive 1.3 ml intrathecal injection of Isobaric Levobupivacaine (0.5%) with 25µg (0.5ml) of injection Fentanyl total dose of 1.8ml  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients of either sex age 18-60yrs belonging to American
Society of Anesthesiologists (ASA) physical status grade I
and II and willing to participate. 
 
ExclusionCriteria 
Details   
 
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 
To compare the time of onset of sensory block.
 		 at 0,2, 5, 10, 15, 20 and 30 min and
thereafter, every 10 min interval till 90 minutes and 30 min intervals thereafter till complete
regression of the block or upto 4 hours.
 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the time of complete regression of motor & sensory block.
 		 0,2, 5, 10, 15, 20 & 30 min &
thereafter, every 10 min interval till 90 minutes & 30 min intervals thereafter till complete
regression of the block or upto 4 hours.  
To compare the magnitude of haemodynamic changes in terms of hypotension &
bradycardia.
 		 0,2, 5, 10, 15, 20 & 30 min &
thereafter, every 10 min interval till 90 minutes & 30 min intervals thereafter till complete
regression of the block or upto 4 hours.  
To compare the incidences of complications (nausea, vomiting, shivering)if any.  0,2, 5, 10, 15, 20 & 30 min &
thereafter, every 10 min interval till 90 minutes & 30 min intervals thereafter till complete
regression of the block or upto 4 hours.  
To compare the time of onset of motor block.  0,2, 5, 10, 15, 20 & 30 min &
thereafter, every 10 min interval till 90 minutes & 30 min intervals thereafter till complete
regression of the block or upto 4 hours.  
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   01/03/2026 
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 Yet Recruiting 
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
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  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 [shagunchahal1301@gmail.comnil].

  6. For how long will this data be available start date provided 01-03-2026 and end date provided 01-03-2027?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   The present study will be a randomized ,double arm ,parallel group double blind active controlled trial and will be conducted at department of anesthesiology and critical care at maharaja agarsen medical college,agroha after approval from IEC .There will be 2 groups group TS(Thoracic segmental spinal with isobaric Levobupivacaine) will receive 1.3ml intrathecal injection of isobaric Levobupivacaine (0.5%) with 0.5ml of Fentanyl and group LS(lumbar spinal with hyperbaric Levobupivacaine )will receive 2.5ml of intrathecal injection of hyperbaric Levobupivacaine (0.5%) and 0.5ml of injection Fentanyl. The study primary outcome will be to compare the time of onset of sensory block which will be assesed by pin prick test and secondary outcome will be to compare the time of onset of motor block , the time of complete regression of motor and sensory block, the magnitude of haemodynamic changes in terms of hypotension and bradycardia, the incidences of complications if any. 
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