| CTRI Number |
CTRI/2024/09/073283 [Registered on: 03/09/2024] Trial Registered Prospectively |
| Last Modified On: |
30/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of Inj Bupivacaine 0.5% and Inj Ropivacaine 0.75% for spinal anesthesia |
|
Scientific Title of Study
|
To compare the anaesthetic and hemodynamic profile Of 0.75 percentage Ropivacaine Heavy And 0.5 percentage bupivacaine Heavy for spinal anaesthesia in patients undergoing lower limb arthroscopic surgeries |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr TULA MAHESH |
| Designation |
Resident in Anesthesiology |
| Affiliation |
INHS ASVINI |
| Address |
Institute of naval medicine, INHS Asvini, Near RC Church, Colaba, Mumbai
Mumbai
MAHARASHTRA
400005
India |
| Phone |
09985851819 |
| Fax |
|
| Email |
tula.mahi1904@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr RS Rajput |
| Designation |
Associate Professor, Anesthesiology |
| Affiliation |
INHS ASVINI |
| Address |
Institute of naval medicine, INHS Asvini, Near RC Church, Colaba, Mumbai
Mumbai
MAHARASHTRA
400005
India |
| Phone |
09968721521 |
| Fax |
|
| Email |
randhir3890rajput@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr TULA MAHESH |
| Designation |
Resident in Anesthesiology |
| Affiliation |
INHS ASVINI |
| Address |
Institute of naval medicine, INHS Asvini, Near RC Church, Colaba, Mumbai
Mumbai
MAHARASHTRA
400005
India |
| Phone |
09985851819 |
| Fax |
|
| Email |
tula.mahi1904@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology and Orthopedics, INHS Asvini |
|
|
Primary Sponsor
|
| Name |
Institute of Naval Medicine |
| Address |
Department Of Anaesthesiology, INHS Asvini, Near RC Church, Colaba, Mumbai 400005 |
| Type of Sponsor |
Other [Armed Forces Institute] |
|
|
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 Tula Mahesh |
Institute of Naval Medicine |
Department Of Anaesthesiology, INHS Asvini, Near RC Church, Colaba, Mumbai 400005
Mumbai
MAHARASHTRA |
9985851819
tula.mahi1904@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute of Naval medicine, INHS Asvini |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S832||Tear of meniscus, current injury, (2) ICD-10 Condition: S832||Tear of meniscus, current injury, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Inj Ropivacaine (Heavy) 0.75% |
Comparison of Anaesthetic (Motor, Sensory) and Hemodynamic Profile .
Dose- Bupivacaine 0.5% (15mg)
Ropivacaine 0.75% (15mg).
Frequency- Once.
Route- Subarachnoid Block
Total Time duration- 24hrs.
|
| Intervention |
Inj. Bupivacaine (Heavy) 0.5% |
Comparison of Anaesthetic (Motor, Sensory) and Hemodynamic Profile .
Dose- Bupivacaine 0.5% (15mg)
Ropivacaine 0.75% (15mg).
Frequency- Once. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA Grade 1 & 2 |
|
| ExclusionCriteria |
| Details |
1. Patients Who Are Unwilling
2. Known Hypersensitivity to Any Of The Test Drug
3. Any Contraindications to Spinal Anaesthesia
4. Cardiac Arrythmias/ Severe Cardiac Disease
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To Compare the spinal block characteristics
1.Onset and duration of analgesia.
2. Hemodynamic changes.
|
18 months (January 2023 to Jun 2024 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Duration of analgesia & anesthesia & time of rescue analgesia |
Eighteen Months |
|
|
Target Sample Size
|
Total Sample Size="104"
Sample Size from India="104"
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 3 |
|
Date of First Enrollment (India)
|
15/09/2024 |
| 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
|
The Spinal Anaesthetia is the widely used method for lower limb orthopedic surgeries, providing a faster onset and effective motor and sensory blockade. It is a simple, easy to perform and has got a definite ednpoint. Comparison of Spinal anesthetic Solutions {Ropivacaine 0.75% (Heavy) And Bupivacaine 0.5% (Heavy)}. Effect On Onset Of Sensory And Motor Blockade, Hemodynamic Changes, duration of analgesia and time for rescue analgesia. |