| CTRI Number |
CTRI/2024/06/068575 [Registered on: 07/06/2024] Trial Registered Prospectively |
| Last Modified On: |
05/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comperative Study Between Inj Ropivacaine And Inj Bupivacaine in participants to know the best among the two. |
|
Scientific Title of Study
|
Comparative Study Between Inj
Hyperbaric
Ropivacaine O.75 Percentage
And Inj Hyperbaric
Bupivacaine 0.5 Percentage In
Spinal Anaesthesia In
Infraumbilical
Surgeries. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mohammed Shoeb |
| Designation |
Postgraduate |
| Affiliation |
MVJ Medical college and Research Hospital |
| Address |
101Ranganath Regency, 2nd main 12th cross, Health layout, Annapurneshwari nagar, BANGALORE
Dept of Anaesthesiology, Dandupalya, hoskote, Bangalore rural
Bangalore Rural
KARNATAKA
560091
India |
| Phone |
9964668479 |
| Fax |
|
| Email |
mohammedshoeb60@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nirmala B.C |
| Designation |
Professor |
| Affiliation |
Rajiv Gandhi University of Health Sciences |
| Address |
No. 191, 2nd cross, 4th main, viveknagar, near post office,
jayanagar 4th block
Bangalore
KARNATAKA
560047
India |
| Phone |
9341285491 |
| Fax |
|
| Email |
nirmalbc.prasad@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mohammed Shoeb |
| Designation |
Postgraduate |
| Affiliation |
Rajiv Gandhi University of Health Sciences |
| Address |
Department of Anaesthesiology MVJ Medical College and Research Hospital.
jayanagar, 4th block
Bangalore
KARNATAKA
560091
India |
| Phone |
9964668479 |
| Fax |
|
| Email |
mohammedshoeb60@gmail.com |
|
|
Source of Monetary or Material Support
|
| MVJ Medical College and Research Hospital
NH75,30th mile, Dandupalya village kolathur, hoskote, Karnataka 562114, INDIA. |
|
|
Primary Sponsor
|
| Name |
MVJ Medical College and Research Hospital |
| Address |
Damdupalya, Hoskote, Banglore 562114 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Dr Nirmala BC |
MVJ Medical College and Research Hospital |
DDpt of Anaesthesiology, Dandupalya, hoskote
Bangalore
KARNATAKA |
9341285491
nirmalbc.prasad@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Mvj medical college and hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bupivacaine |
Dose- 3.2ml
Route- subarachnoid.
Frequency- single dose.
Total Duration- until first rescue analgesia. |
| Intervention |
Ropivacaine |
Dose- 3.2ml
Route- subarachnoid.
Frequency- single dose
Total Duration- until first rescue analgesia |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Height 150cms - 180cms.
Weight 50 to 80kgs.
ASA physical status Grade I and II.
Patients undergoing elective surgeries under Spinal Anaesthesia. |
|
| ExclusionCriteria |
| Details |
Intra op change of plan of anaesthesia.
Obstetric surgeries.
Any Intra-op Blood transfusion cases will be excluded from the study.
Patients with spine deformity.
Patients with neurological defects.
Patients with previous history of spine surgery.
Patients with infection in and around the area of spinal procedure. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Onset, time of first rescue analgesia and duration of analgesia |
Observed every 10 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hemodynamic parameters & side effects |
Every 10 minutes |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 2 |
|
Date of First Enrollment (India)
|
17/06/2024 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
Intrathecal anaesthesia has replaced general anaesthesia as first line method to provide anaesthesia for infraumbilical surgeries as it is very economical and easy to administer.
The efficacy of 0.75% ropivacaine is similar to that of 0.5% bupivacaine
Ropivacaine has an advantage of reduced potential for CNS toxicity and cardiotoxocity and faster recovery. |