| CTRI Number |
CTRI/2023/05/052439 [Registered on: 10/05/2023] Trial Registered Prospectively |
| Last Modified On: |
09/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of isobaric and hyperbaric Ropivacaine in spinal anaesthesia in lower limb surgeries |
|
Scientific Title of Study
|
Comparison of isobaric and hyperbaric ropivacaine in spinal anaesthesia in lower limb surgeries- A Randomised controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
M Ragu Ram |
| Designation |
First year postgraduate |
| Affiliation |
SRI VENKATESHWARAA MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
| Address |
No.42,4th cross annai theresa nagar,moolakulam
No.13-A,Pondy-villupuram main road,ariyur,Puducherry
Pondicherry
PONDICHERRY
605102
India |
| Phone |
9443602899 |
| Fax |
|
| Email |
rrsw1112@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr RADHA KRISHNAN |
| Designation |
PROFESSOR |
| Affiliation |
|
| Address |
Department of Anaesthesiology,Sri Venkateshwaraa College Hospital and Research centre,No.13-A,Pondy-Villupuram main road,Ariyur,Puducherry
Pondicherry
PONDICHERRY
605102
India |
| Phone |
8825778958 |
| Fax |
|
| Email |
rkpuduvai@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrRADHA KRISHNAN |
| Designation |
PROFESSOR |
| Affiliation |
|
| Address |
Department of Anaesthesiology,Sri Venkateshwaraa College Hospital and Research centre,No.13-A,Pondy-Villupuram main road,Ariyur,Puducherry
Pondicherry
PONDICHERRY
605102
India |
| Phone |
8825778958 |
| Fax |
|
| Email |
rkpuduvai@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRI VENKATESHWARAA COLLEGE HOSPITAL AND RESEARCH CENTRE, No.13A,Pondy-villupuram main road,Ariyur,Puducherry |
|
|
Primary Sponsor
|
| Name |
Ragu Ram M |
| Address |
Sri venkateshwaraa medical college hospital and reasearch centre
no.13A,Pondy villupuram main road,Ariyur,Puducherry |
| 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 |
| Ragu Ram M |
Department Of Anaesthesiology |
Sri Venkateshwaraa Medical college and hospital and Research centre, No.8,Pondy-Villupuram Main road,Ariyur,Puducherry
Pondicherry
PONDICHERRY |
8667274140
rrsw1112@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
SPINAL ANAESTHESIA |
Comparison of isobaric and hyperbaric ropivacaine in spinal anaesthesia in lower limb surgeries- A Randomised controlled trial |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
•Age 18-50 years of both sex
•American Society of Anaesthesia (ASA) grading I and II
•Patient undergoing Lower limb surgeries
|
|
| ExclusionCriteria |
| Details |
Patient refusal
Infection at the site of injection
Patient with psychiatric illness
Pregnant woman
Allergic to local anaesthetics |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hyperbaric Ropivacaine will show prolonged duration of sensory and motor blockade when compared to isobaric Ropivacaine in spinal anaesthesia in lower limb surgeries |
Sensory blockade will be assesed by spirit swab method method,motor blockade will be assesed by modified bromage scaleand post operative pain will be assesed by Visual analogue scale at 30min,2hrs,6hrs and 24hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hyperbaric Ropivacaine will show prolonged duration of sensory and motor blockade when compared to isobaric Ropivacaine in spinal anaesthesia in lower limb surgeries |
Sensory blockade will be assesed by spirit swab method method,motor blockade will be assesed by modified bromage scaleand post operative pain will be assesed by Visual analogue scale at 30min,2hrs,6hrs and 24hrs |
|
|
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 1 |
|
Date of First Enrollment (India)
|
19/05/2023 |
| 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
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is to compare isobaric and hyperbaric Ropivacaine in spinal anaesthesia in lower limb surgeries.Hypothesis of my study is hyperbaric Ropivacaine will show prolonged duration of sensory and motor blockade when compared to isobaric Ropivacaine. |