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CTRI Number  CTRI/2024/06/069543 [Registered on: 26/06/2024] Trial Registered Prospectively
Last Modified On: 25/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To evaluate and compare the efficacy and adverse effects of combination levobupivacaine heavy with morphine versus bupivacaine heavy with morphine in lscs under Spinal anaesthesia 
Scientific Title of Study   Comparative evaluation of intrathecal anaesthetic efficacy of combination of hyperbaric levobupivacaine with morphine versus hyperbaric bupivacaine with morphine in caesarean section- a double blinded randomized clinical 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  MAHIN PRABHU  
Designation  JUNIOR RESIDENT 
Affiliation  JSS ACADEMY OF HIGHER EDUCATION AND RESEARCH 
Address  DEPARTMENT OF ANAESTHESIOLOGY JSS HOSPITAL,MYSURU Mysore KARNATAKA 570004 India

Mysore
KARNATAKA
570004
India 
Phone  9094838876  
Fax    
Email  mahinprabhu96@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR ANIL KUMAR M R 
Designation  PROFESSOR 
Affiliation  JSS ACADEMY OF HIGHER EDUCATION AND RESEARCH 
Address  DEPARTMENT OF ANAESTHESIOLOGY JSS HOSPITAL,MYSURU Mysore KARNATAKA 570004 India

Mysore
KARNATAKA
570004
India 
Phone  9945155844  
Fax    
Email  dranilkumarmr@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR ANIL KUMAR M R  
Designation  PROFESSOR 
Affiliation  JSS ACADEMY OF HIGHER EDUCATION AND RESEARCH 
Address  DEPARTMENT OF ANAESTHESIOLOGY JSS HOSPITAL,MYSURU Mysore KARNATAKA 570004

Mysore
KARNATAKA
570004
India 
Phone  9945155844  
Fax    
Email  dranilkumarmr@gmail.com  
 
Source of Monetary or Material Support  
JSS MEDICAL COLLEGE AND HOSPITAL Mahatma Gandhi Road, Fort Mohalla, Mysuru, Karnataka 570004 
 
Primary Sponsor  
Name  JSS ACADEMY OF HIGHER EDUCATION AND RESEARCH 
Address  JSS MEDICAL COLLEGE AND HOSPITAL,MYSURU 
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 MAHIN PRABHU S  JSS MEDICAL COLLEGE AND HOSPITAL  Pregnant females posted for elective caesarean section in 2nd floor OT complex, JSS hospital,MG ROAD , Agrahara,MYSURU,Karnataka 570004
Mysore
KARNATAKA 
9094838876

mahinprabhu96@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JSS Academy Of Higher Education And 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  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)- COMBINATION OF HYPERBARIC LEVOBUPIVACAINE WITH MORPHINE 1.After spinal anesthesia inj. hyperbaric levobupivacaine 2ml with inj. morphine 100mcg given intrathecally and intraoperative quality of anesthesia, hemodynamic parameters are monitored and compared.
2Comparator Arm (Non Ayurveda)- COMBINATION OF HYPERBARIC BUPIVACAINE WITH MORPHINE 1.After spinal anesthesia inj. hyperbaric bupivacaine 2ml with inj. morphine 100mcg given intrathecally and intraoperative quality of anesthesia, hemodynamic parameters are monitored and compared.
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Parturients of ASA II aged 20 to 40 years with gestational age between 37-42 weeks planned foe elective caesaren section 
 
ExclusionCriteria 
Details  Patient refusal
Multiple pregnancy
BMI>30
Patienta with known history of PIH and GDM
Any contraindications to spinal anaesthesia 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess and compare the time taken by the drugs to achieve maximum sensory level and motor blockade   From the commencement of sensory and motor blockade till post operative regression of motor and sensory. 
 
Secondary Outcome  
Outcome  TimePoints 
a) To assess the hemodynamic parameters.
b) To evaluate postoperative pain.
c)To monitor for any side effects.
 
From the commencement of spinal anaesthesia till post operative recovery period 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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 1/ Phase 2 
Date of First Enrollment (India)   06/07/2024 
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 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 - NO
Brief Summary  

90 parturients, belonging American Society of Anaesthesiologists Physical status (ASA-PS) class II planned for elective lower segment caesarean section (LSCS) under spinal anaesthesia (SA), will be thoroughly evaluated as a part of preanaesthetic evaluation, 24hours prior to the procedure. Fasting of 6 hours for solids and 2 hours for clear liquids will be ensured. Intravenous (IV) access will be secured in the ward as per our institutional policy. All patients will be randomised into two groups using shuffled sealed opaque envelop (SNOSE) technique.

Group B- Will receive 10mg (2ml) of 0.5% hyperbaric bupivacaine-(H) and 100mcg morphine.

Group L- Will receive 10mg(2ml) of 0.50 % hyperbaric levobupivacaine (H) and 100mcg morphine.

To ensure blinding, the anaesthesiologist who performs spinal anaesthesia will not be further involved in the study. A different anaesthesiologist designated as the observer will only enter the operation theatre after spinal anaesthesia has been administered. Neither the observer nor the parturient will be disclosed any information regarding which drug to be administered. Hence the observer and the parturient will be blinded for the study.

In the operation theatre standard monitoring devices will be attached, including electrocardiography (ECG), automated NIBP (non-invasive blood pressure), pulse oximetry (SpO2) and baseline values of SBP (systolic blood pressure), DBP (diastolic blood pressure), MAP (mean arterial pressure) will be recorded. The hemodynamic multiparameter monitor will be placed in the direct line of vision of the anaesthesiologist performing the Spinal Anaesthesia. Spinal anaesthesia will be administered using 25 G Quincke’s needle at the L2–L3 or L3–L4 interspace in sitting position. Immediately after administration of spinal anaesthesia, the parturient will be made to lie down in supine posture with 10 cm wedge beneath the right buttock.

Intraoperatively sensory blockade will be checked using pin prick method and motor blockade will be checked by modified Bromage score. The level of sensory and motor block will be assessed every 1 minute for the 1st 10 minutes and every 5 minutes till the completion of the surgery. Surgery will be allowed to start once the sensory level reaches T6 level.

Any hypotension, defined as a decrease in systolic blood pressure of < 20% below baseline, will be managed using 6 mg of intravenous ephedrine.

Heart rate will be monitored every minute for the first 10 mins and every 5 mins for the next 30mins Any bradycardia with heart rate < 60bpm will be managed by using 0.6mg of intravenous atropine.

Perioperatively subjects will be followed up till they regain their motor power and sensation. In the immediate postoperative period, all patients will receive intravenous Inj. Paracetamol 1g 6th hourly. Postoperative analgesia will be assessed using VAS score and a rescue analgesic of Inj. Diclofenac will be given if the VAS score is found to be greater than or equal to 3.

 
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