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CTRI Number  CTRI/2024/12/078662 [Registered on: 27/12/2024] Trial Registered Prospectively
Last Modified On: 26/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A PROSPECTIVE RANDOMISED COMPARATIVE STUDY OF HYPERBARIC ROPIVACINE VS HYPERBARIC LEVOBUPIVACAINE IN SPINAL ANAESTHESIA  
Scientific Title of Study   A COMPARATIVE STUDY OF HYPERBARIC ROPIVACAINE VS HYPERBARIC LEVOBUPIVACAINE IN SPINAL 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  DR ASHISH RAJ  
Designation  POSTGRADUATE  
Affiliation  DR D Y PATIL UNIVERSITY AND SCHOOL OF MEDICINE  
Address  A-Block Department of Anesthesia D Y Patil School of Medicine Ayyappa Temple Road Dr D Y Patil Vidyanagar Sector 5 Nerul Navi Mumbai

Thane
MAHARASHTRA
400706
India 
Phone  9370724233  
Fax    
Email  xmini758@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR ANURADHA MALLIWAL  
Designation  PROFESSOR  
Affiliation  DR D Y PATIL UNIVERSITY AND SCHOOL OF MEDICINE  
Address  A-Block Department of Anesthesia D Y Patil School of Medicine Ayyappa Temple Road Dr D Y Patil Vidyanagar Sector 5 Nerul Navi Mumbai

Thane
MAHARASHTRA
400706
India 
Phone  9920318482  
Fax    
Email  anumalliwal@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR ANURADHA MALLIWAL  
Designation  PROFESSOR  
Affiliation  DR D Y PATIL UNIVERSITY AND SCHOOL OF MEDICINE  
Address  A-Block Department of Anesthesia D Y Patil School of Medicine Ayyappa Temple Road Dr D Y Patil Vidyanagar Sector 5 Nerul Navi Mumbai

Thane
MAHARASHTRA
400706
India 
Phone  9920318482  
Fax    
Email  anumalliwal@gmail.com  
 
Source of Monetary or Material Support  
D Y Patil University School of Medicine and Hospital, Nerul, Navi Mumbai Department of Anaesthesiology 
 
Primary Sponsor  
Name  D Y Patil University School of Medicine and Hospital Nerul Navi Mumbai  
Address  A-Block Department of Anesthesia D Y Patil School of Medicine Ayyappa Temple Road Dr D Y Patil Vidyanagar Sector 5 Nerul Navi Mumbai  
Type of Sponsor  Research institution and hospital 
 
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 
DrAshish Raj   D.Y.Patil University School of Medicine and Hospital ,Nerul,Navi Mumbai  A-Block Department of Anesthesia D.Y Patil School of Medicine, Ayyappa Temple Rd, Dr D Y Patil Vidyanagar, Sector 5, Nerul, Navi Mumbai
Thane
MAHARASHTRA 
9370724233

xmini758@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The Institutional Ethics Committee for Biomedical and Health research of Dr D Y Patil Medical college and hospital   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 4||Measurement and Monitoring,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Hyperbaric Levobupivacaine 0.5% in spinal anaesthesia   Dose -3cc of 0.5% hyperbaric Levobupivacaine Route of administration- Subarachnoid space 
Intervention  Hyperbaric Ropivacaine 0.75% in Spinal Anaesthesia   Dose - 3cc of 0.75% Hyperbaric Ropivacaine Route of Administration - Subarachnoid Space 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patient undergoing various infra-umbilical surgeries under spinal anaesthesia ,Asa grade 1 and 2, Age 18-60 years 
 
ExclusionCriteria 
Details  Refusal ofspinal anaesthesia
Asa grade 3 and 4
Head injury and raised ICP
Psychiatric diseases
Known allergy to test drug
Infection at site of injection
Uncontrolled hypovolemia
Coagulopathies
Fixed cardiac output ststes 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the efficacy of Ropivacaine and Levobupivacaine based on :
a)Onset and duration of sensory blockade
b)Onset and duration of motor blockade
 
To compare the efficacy of Ropivacaine and Levobupivacaine based on :
a)Onset and duration of sensory blockade
b)Onset and duration of motor blockade
 
 
Secondary Outcome  
Outcome  TimePoints 
To compare in the two groups:
1)Maximum height of sensory blockade,
2) Hemodynamic effects
3)Complications or side effects if any .
 
In 3 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 4 
Date of First Enrollment (India)   26/01/2025 
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)  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 anaesthesia is a regional anaesthesia technique in which minimal doses of intrathecal local anaesthetic agents are used so that only the nerve roots supplying specific areas are anaesthetised.
• Hyperbaric bupivacaine injection is the most commonly used drug for spinal anaesthesia. It causes a long-lasting motor block associated with hypotension and bradycardia, which eliminates it as the drug of choice for day care surgeries.
• Day care surgery is suited to provide patient centered treatment, which allows them to receive treatment as per their needs and to return home on the day of surgery and recover in a familiar home enviornment.
• The increased in no. of day care surgeries has resulted in quest for alternative local anaesthetics and combinations which can produce spinal anaesthesia of relatively shorter duration with better haemodynamic stability.
• Ropivacaine and Levobupivacaine are newer local anaesthetics which appear to have a favourable profile.
• Ropivacaine is the ‘S’ isomer of the propyl analogue of bupivacaine with long duration of action, low lipid solubility, low potency and low cardiovascular and CNS toxicity. It blocks nerve fibres involved in pain transmission (Aδ and C fibres) to a greater degree than those controlling motor function (Aβ fibres).
• Levobupivacaine, a pure S(-) enantiomer of bupivacaine is also a long acting amide local anaesthetic which produces differential neuraxial block, that is, early onset and prolonged duration of sensory block with shorter duration of motor block and has lower cardiac toxicity.
• Clinical studies have shown that ropivacaine and levobupivacaine are equally effective. However, levobupivacaine has lower affinity for sodium channels in the heart and therefore it is less frequently associated with cardiovascular events.
• Hyperbaric local anaesthetic solution is heavier than cerebrospinal fluid at 37 °C. Spread of hyperbaric solution depends on position of patients; in head up position, it spreads caudally and in head down position, it spread in cephalic direction. Hyperbaric solution will preferentially spread to the dependent regions of the spinal canal.
• Hyperbaric local anaesthetics injected at the L3-L4 interspace will spread from the height of lumbar lordosis down toward the trough of thoracic kyphosis, resulting in a higher level of anaesthetic effect than isobaric or hypobaric solutions.
• A randomised comparative study will be conducted to assess the efficacy of the newer local anaesthetic agents ropivacaine and levobupivacaine in spinal anaesthesia.
 

 
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