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CTRI Number  CTRI/2025/07/090371 [Registered on: 07/07/2025] Trial Registered Prospectively
Last Modified On: 03/07/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparing Two Methods of Giving Spinal Anesthesia (Fractional vs. Single Dose) in Patients Undergoing Lower Abdominal or Leg Surgery: A Study on Safety and Effectiveness 
Scientific Title of Study   Comparative Study on the Effect of Fractional versus Bolus Dose of Levobupivacaine Used in Spinal Anesthesia in Patients Undergoing Lower Abdominal and Lower Limb Orthopedic Surgery: A Prospective Randomized Controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kashish Garg 
Designation  Assistant Professor 
Affiliation  PGIMER Satellite Centre Sangrur 
Address  Department of anaesthesia and intensive care

Sangrur
PUNJAB
148001
India 
Phone  09501188562  
Fax    
Email  kashishg83@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Kashish Garg 
Designation  Assistant Professor 
Affiliation  PGIMER Satellite Centre Sangrur 
Address  Department of anaesthesia and intensive care

Sangrur
PUNJAB
148001
India 
Phone  09501188562  
Fax    
Email  kashishg83@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Kashish Garg 
Designation  Assistant Professor 
Affiliation  PGIMER Satellite Centre Sangrur 
Address  Department of anaesthesia and intensive care

Sangrur
PUNJAB
148001
India 
Phone  09501188562  
Fax    
Email  kashishg83@gmail.com  
 
Source of Monetary or Material Support  
Post graduate Institute of Medical Education and Research  
 
Primary Sponsor  
Name  Dr Kashish Garg 
Address  Department of Anaesthesia and Intensive Care, PGIMER Satellite Centre Sangrur 
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 Kashish Garg  PGIMER Satellite Centre Sangrur Punjab  Department of anaesthesia and intensive care PGIMER Satellite Centre Sangrur Punjab 148001 Chandigarh india
Sangrur
PUNJAB 
09501188562

kashishg83@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Postgraduate Institute of Medical Education and Research Chandigarh  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 spinal anaesthesia technique  o A dose of 15 mg levobupivacaine (0.5%) will be injected intrathecally in a single bolus dose manner. o Patients will be positioned supine immediately after administration  
Intervention  Fractional Spinal Anaesthesia technique  o The 15 mg dose is divided into two equal portions. o The second half dose is administered after a 45-second interval while maintaining needle placement. o Patient will be positioned supine immediately after administration  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  o ASA physical status I or II.
undergoing elective lower abdominal or lower limb orthopedic surgeries. 
 
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 
1. Fall in mean blood pressure
2. Total number of doses of vasopressor required 
Recorded at baseline and immediately after administering Spinal Anaesthesia, followed by every 2 minutes for the first 10 minutes of administering Spinal Anaesthesia, followed by every 3 min till the next 30 min, followed by every 5 minutes until surgery gets over
• Assessment will be done every 30 minutes in the postoperative period till sensory and motor variables returns back to normal
 
 
Secondary Outcome  
Outcome  TimePoints 
1.Onset & duration of sensory & motor blockade.
2.Highest sensory block level achieved.
3.Post-operative pain & time to first rescue analgesia.
4.Incidence of adverse events (e.g., nausea, vomiting, shivering, respiratory distress).
 
Recorded at baseline & immediately after administering Spinal Anaesthesia, followed by every 2 minutes for the first 10 minutes of administering Spinal Anaesthesia, followed by every 3 min till the next 30 min, followed by every 5 minutes until surgery gets over
• Assessment will be done every 30 minutes in the postoperative period till sensory & motor variables returns back to normal
 
 
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   N/A 
Date of First Enrollment (India)   01/08/2025 
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 - NO
Brief Summary  

Spinal anesthesia is a commonly used technique for lower abdominal and limb surgeries due to its rapid onset and cost-effectiveness. However, it often causes hemodynamic disturbances like hypotension and bradycardia. To mitigate these effects, fractional spinal anesthesia—administering the anesthetic in divided doses—has emerged as a promising technique, allowing gradual onset of sympathetic blockade and greater hemodynamic stability.

Levobupivacaine, the S(-) enantiomer of bupivacaine, is favored for spinal anesthesia due to its reduced cardiotoxicity and better hemodynamic profile. Despite extensive use, most studies evaluating levobupivacaine have focused on bolus dosing, leaving the potential benefits of fractional dosing underexplored.

This prospective randomized controlled trial aims to compare the effects of fractional versus bolus dosing of intrathecal levobupivacaine in patients undergoing lower abdominal and orthopedic limb surgeries. The primary focus is on hemodynamic stability—specifically, the incidence of significant blood pressure drops and vasopressor requirements. Secondary outcomes include onset and duration of sensory/motor blockade, highest block level, postoperative pain, and adverse events.

By investigating a safer, more stable approach to spinal anesthesia, especially for patients with cardiovascular risk, this study seeks to optimize anesthetic techniques for improved patient outcomes and reduced intraoperative complications.

 
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