| 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
|
|
|
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
|
|
|
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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