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CTRI Number  CTRI/2024/01/061492 [Registered on: 15/01/2024] Trial Registered Prospectively
Last Modified On: 13/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing intrathecal levobupivacaine with bupivacaine for infraumbilical surgeries  
Scientific Title of Study   Comparison of intrathecal levobupivacaine with bupivacaine in adult patients undergoing infraumbilical surgeries under neuraxial anaesthesia 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Maj Dr Lalita Sharma 
Designation  PG Resident 
Affiliation  Command Hospital EC Kolkata 
Address  Department of Anaesthesiology and Critical Care 2nd Floor Command Hospital EC Alipore, Kolkata

Kolkata
WEST BENGAL
700027
India 
Phone  7890779836  
Fax    
Email  latikasnmc@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Col Dr Deepak Dwivedi 
Designation  Professor,Department of Anaesthesiology and Critical Care 
Affiliation  Command Hospital EC Kolkata 
Address  Department of Anaesthesiology and Critical Care 2nd Floor Command Hospital EC Alipore, Kolkata

Kolkata
WEST BENGAL
700027
India 
Phone  8195915566  
Fax    
Email  deepakdwivedi739@gmail.com  
 
Details of Contact Person
Public Query  
Name  Lt Col Dr Abraham L C 
Designation  Assistant Professor,Department of Anaesthesiology and Critical Care 
Affiliation  Command Hospital EC Kolkata 
Address  Department of Anaesthesiology and Critical Care 2nd Floor Command Hospital EC Alipore, Kolkata

Kolkata
WEST BENGAL
700027
India 
Phone  8755999223  
Fax    
Email  lalchhana2312@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology and Critical Care 2nd Floor Command Hospital EC Alipore, Kolkata 
 
Primary Sponsor  
Name  Maj Dr Lalita Sharma 
Address  Department of Anaesthesiology and Critical Care 2nd Floor Command Hospital EC Alipore, Kolkata 
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 
Maj Dr Lalita Sharma  Department of Anaesthesiology and Critical Care 2nd Floor Command Hospital EC Alipore, Kolkata  17/1E,Alipore Road,Alipore Police Line,Alipore.
Kolkata
WEST BENGAL 		 7890779836

latikasnmc@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE COMMAND HOSPITAL  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, (2) ICD-10 Condition: O||Medical and Surgical, (3) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Levobupivacaine and bupivacaine   Comparison between hyperbaric levobupivacaine (3ml of 0.5%) and bupivacaine (3ml of 0.5%) with respect to duration of anaesthesia,motor blockade,analgesia,incidence of intraoperative hypotension,bradycardia in patients undergoing infraumbilical surgeries under neuraxial anaesthesia.The duration of intervention will be for 02 hrs 
Intervention  Neuraxial Block  comparison between hyperbaric levobupivacaine and levobupivacaine with respect to duration of anaesthesia,motor blockade,analgesia,incidence of intraoperative hypotension,bradycardia in patients undergoing infraumbilical surgeries under neuraxial anaesthesia.The total duration of such intervention is 2 hrs. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  ASA physical status I to II
Age 18-50yrs
Elective Surgeries
Height >150 cms
 
 
ExclusionCriteria 
Details  History of severe headache and migraine.
Failure to achieve desired motor or sensory blockade
Neurological deficit
Emergency surgeries
Increased intracranial pressure
Coagulation and bleeding disorders
Infection at the site of needle insertion
Spine deformities
Spinal Anaesthesia converted to General Anaesthesia 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Comparison of duration of anaesthesia.
 		 Outcome of the study will be observed after the
end of surgery and patients recover to
preoperative condition.

 
 
Secondary Outcome  
Outcome  TimePoints 
Total duration of motor block.
Total duration of analgesia.
Incidence of hypotension and bradycardia.

 		 every min till 10 min, at the end of surgery and
every 30 min thereafter till complete recovery
achieved 
 
Target Sample Size   Total Sample Size="82"
Sample Size from India="82" 
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)   25/01/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  25/01/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="10"
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 - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  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 [latikasnmc@gmail.com].

  6. For how long will this data be available start date provided 01-12-2025 and end date provided 01-12-2036?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Both groups were comparable regarding age, ASA grade,duration of surgery and preoperative vital parameters.After obtaining valid consent and applying inclusion and exclusion criteria patients undergoing infraumbilical surgeries under Neuraxial Anaesthesia will be randomized into two groups – A (Intrathecal hyperbaric Levobupivacaine) & B (Intrathecal hyperbaric racemic Bupivacaine) during Pre-Anaesthetic assessment.
After a pre-anaesthetic evaluation, patients aged between 18-55 year, height >150 cms and planned for infra-umbilical surgery will be included in the study. Patients having uncontrolled systemic illness or any contraindication to spinal anaesthesia will be excluded from recruitment.Patients will be admitted on the evening prior to surgery and will be asked to avoid solid food for 8 h prior to the scheduled time of surgery. However, will be allowed to take clear liquids up to 2 h before surgery. After shifting the patient to the operating theatre, standard monitoring (ECG, HR, NIBP, pulse oximetry) will be ensued. The baseline values of heart rate (HR) and blood pressure (BP) will be noted. After securing an 18-G intravenous catheter, patients will be preloaded with 10 ml/kg of Ringer’s lactate over 10 min. Before commencement of anaesthesia, patients will be briefed about the method of sensory and motor assessment. A sub-arachnoid block will be performed in sitting position, at the L2/L3 or L3/L4 intervertebral space using a 25 G Quincke spinal needle. After confirming free flow of cerebrospinal fluid, the study drug, as per group allocation, will be given slowly over 15 s.

Group 1(n=41):3ml of 0.5% Levobupivacaine (hyperbaric).

Group 2(n=41):3ml of 0.5% Bupivacaine (hyperbaric).

Immediately after the intrathecal injection, the patient will be placed in supine position. An anaesthesiologist, blinded to the local anaesthetic used, will assess the sensory and motor blockade. The study also evaluates the incidence of bradycardia and hypotension intraoperatively.

 
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