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CTRI Number  CTRI/2023/10/058567 [Registered on: 12/10/2023] Trial Registered Prospectively
Last Modified On: 11/10/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparative evaluation of two spinal anesthesia drugs for elective Cesarean section 
Scientific Title of Study   A comparative evaluation of intrathecal hyperbaric levobupivacaine 0.5% with hyperbaric bupivacaine 0.5% for elective cesarean section : A prospective randomised study. 
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 HARMEEN SINGH GURMEET SINGH CHHABADA 
Designation  JUNIOR RESIDENT 
Affiliation  MGMIHS , Kamothe , Navi Mumbai. 
Address  PLOT NO 46 SINDHI COLONY AURNGABAD DEPARTMENT OF ANESTHESIA MGM MEDICAL COLLEGE AND HOSPITAL AURANGABAD MAHARASHTRA
PLOT NO 46 SINDHI COLONY AURNGABAD DEPARTMENT OF ANESTHESIA MGM MEDICAL COLLEGE AND HOSPITAL AURANGABAD MAHARASHTRA
Aurangabad
MAHARASHTRA
431001
India 
Phone  8390633361  
Fax    
Email  drharmeensingh@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR V M SASTURKAR 
Designation  PROFESSOR  
Affiliation  MGM MEDICAL COLLEGE AND HOSPITAL AURANGABAD 
Address  DEPARTMENT OF ANESTHESIA MGM MEDICAL COLLEGE AND HOSPITAL N6 CIDCO AURANGABAD MAHARASHTRA
DEPARTMENT OF ANESTHESIA MGM MEDICAL COLLEGE AND HOSPITAL N6 CIDCO AURANGABAD MAHARASHTRA
Aurangabad
MAHARASHTRA
431003
India 
Phone  9370668196  
Fax    
Email  vasantims@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  DR V M SASTURKAR 
Designation  PROFESSOR  
Affiliation  MGM MEDICAL COLLEGE AND HOSPITAL AURANGABAD 
Address  DEPARTMENT OF ANESTHESIA MGM MEDICAL COLLEGE AND HOSPITAL N6 CIDCO AURANGABAD MAHARASHTRA
DEPARTMENT OF ANESTHESIA MGM MEDICAL COLLEGE AND HOSPITAL N6 CIDCO AURANGABAD MAHARASHTRA
Aurangabad
MAHARASHTRA
431003
India 
Phone  9370668196  
Fax    
Email  vasantims@rediffmail.com  
 
Source of Monetary or Material Support  
MGM MEDICAL COLLEGE AND HOSPITAL AURANGABAD MAHARASHTRA 
 
Primary Sponsor  
Name  MGM MEDICAL COLLEGE AND HOSPITAL AURANGABAD 
Address  DEPARTMENT OF ANESTHESIA MGM MEDICAL COLLEGE AND HOSPITAL N6 CIDCO AURANGABAD MAHARASHTRA 
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 
DR HARMEEN SINGH GURMEET SINGH CHHABADA  MGM MEDICAL COLLEGE AND HOSPITAL AURANGABAD  MGM MEDICAL COLLEGE AND HOSPITAL N6 CIDCO AURANGABAD MAHARASHTRA
Aurangabad
MAHARASHTRA 		 8390633361

drharmeensingh@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
MGMS ETHICS COMMITTEE FOR RESEARCH ON HUMAN SUBJECTS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O82||Encounter for cesarean delivery without indication,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  INTRATHECAL 0.5% HYPERBARIC BUPIVACAINE  All the patients will be screened before enrollment in study. Consent for participation in study will be obtained from patients.Group B (COMPARATIVE) having 35 patients will recieve intrathecal 0.5% hyperbaric bupivacaine. On the day of the surgery in operation theatre, parameters like heart rate (HR), non invasive mean blood pressure (MAP), oxygen saturation (spo2), ecg will be recorded . Spinal anesthesia will be administered in sitting position.Sensory block will be tested by pin prick in mid axillary line. Onset ,duration,maximum height of sensory block will be noted. Motor block will be tested using modified bromage scale. Onset and duration of motor block will be noted. The duration of the study will be 2 years. 
Intervention  INTRATHECAL 0.5% HYPERBARIC LEVOBUPIVACAINE   All the patients will be screened before enrollment in study. Consent for participation in study will be obtained from patients.Group L (intervention) having 35 patients will recieve intrathecal 0.5% hyperbaric levobupivacaine. On the day of the surgery in operation theatre, parameters like heart rate (HR), non invasive mean blood pressure (MAP), oxygen saturation (spo2), ecg will be recorded . Spinal anesthesia will be administered in sitting position.Sensory block will be tested by pin prick in mid axillary line. Onset ,duration,maximum height of sensory block will be noted. Motor block will be tested using modified bromage scale. Onset and duration of motor block will be noted. The duration of the study will be 2 years. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1. Pregnant Females between age 18 to 40 years.
2. Patients belonging to ASA grade 1 and 2.
3. Subjects willing to sign informed consent for participation in study 
 
ExclusionCriteria 
Details  1. Patients under going caesearian section for fetal distress and hypertensive disorders
of pregnancy.
2. Known allergy to the study drug
3. History of Liver, Renal & Cardiac diseases.
4. BMI > 30
5.Height <150cm and >180cm 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
A COMPARATIVE EVALUATION OF INTRATHECAL HYPERBARIC LEVOBUPIVACAINE 0.5% WITH HYPERBARIC BUPIVACAINE 0.5% FOR ELECTIVE CESAREAN SECTION  1.ONSET OF SENSORY BLOCK
2.MAXIMUM HEIGHT OF SENSORY BLOCK
3.DURATION OF SENSORY BLOCK
4.ONSET OF MOTOR BLOCK
5.DURATION OF MOTOR BLOCK 
 
Secondary Outcome  
Outcome  TimePoints 
Hemodynamic parameters (Heart Rate and Mean Arterial Pressure).
Side effects like nausea, vomiting, bradycardia and Hypotension.
Neonatal APGAR score 		 at the deliver of baby and throughout the surgery. 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   22/10/2023 
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="6"
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 - NO
Brief Summary   Spinal Anesthesia is accepted as a safe technique for cesarean section worldwide. With the increasing number of cesarean section under spinal anesthesia various local anesthetic agents are being studied for their efficacy, hemodynamic stability and other effects . Hyperbaric bupivacaine is most commonly used local anesthetic agent in elective cesarean section.
Bupivacaine is racemic mixture of dextro and levo and provides dense sensory and motor block which may lead to prolonged immobilization and hypotension.
Enantiomers may have the same desired pharmacological properties but fewer side effects. Levobupivacaine , the s enantiomer has shown to provide a more selective neuraxial blockade  than racemic bupivacaine.
Hyperbaric levobupivacaine was commercially not available previously but as of now, hyperbaric solutions are available in India . The claimed benifits of these agents have reduced cardiac toxicity and more specific effects on sensory rather than motor nerve fibers . The decreased toxicity of levobupivacaine is attributed to it faster binding rate.
 
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