| CTRI Number |
CTRI/2017/08/009352 [Registered on: 11/08/2017] Trial Registered Prospectively |
| Last Modified On: |
11/08/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
comparing drugs ropivacaine and bupivacaine as local anesthesia for upper limb surgeries |
|
Scientific Title of Study
|
Comparative study on efficacy of Ropivacaine and Bupivacaine for supraclavicular brachial plexus block. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shivakumara K C |
| Designation |
Post Graduate |
| Affiliation |
Father mullers medical college, mangalore |
| Address |
Room no-331,Don bosco Boys Hostel,Kankanady,Father Mullers Medical college, Mangalore.
S/O Chikkanna K,Halivana(Post)
Harihara (Taluk) Davanagere (District)
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9071120214 |
| Fax |
|
| Email |
shivukc007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mahabala T H |
| Designation |
Professor |
| Affiliation |
Father Mullers Medical College,Mangalore |
| Address |
Father Mullers Medical College
Kankanady
Mangalore
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9845227831 |
| Fax |
|
| Email |
drmahabalath@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mahabala T H |
| Designation |
Professor |
| Affiliation |
Father Mullers Medical College,Mangalore |
| Address |
Father Mullers Medical College
Kankanady
Mangalore
Shimoga
KARNATAKA
575002
India |
| Phone |
9845227831 |
| Fax |
|
| Email |
drmahabalath@gmail.com |
|
|
Source of Monetary or Material Support
|
| Father muller medical college hospital,Mangalore |
|
|
Primary Sponsor
|
| Name |
Father Mullers Medical College |
| Address |
Father Mullers Medical College,Father muller Road Kankanady,Mangalore 575002 |
| 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 |
| Shivakumara K C |
Father Muller medical college hospital,Mangalore |
Basement floor,main OT complex Anesthesiology department
Dakshina Kannada
KARNATAKA |
9071120214
shivukc007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Father Muller Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients undergoing upperlimb surgeries, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients of aged between 20 to 60 years
Elective upper limb surgery cases |
|
| ExclusionCriteria |
| Details |
Patients with known hypersensitivity to drugs
Pregnant patients |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the ropivacaine and bupivacaine in terms of onset,duration of sensory and motor blockade |
March 2018 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Ropivacaine is a local anaesthetic with a chemical formula of amino amides and less toxic.Now comparing ropivacaine and bupivacaine for supraclavicular brachial plexus block. |
0 to 120 minutes |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
14/09/2017 |
| 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
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
To compare the efficacy of Ropivacaine and Bupivacaine in terms of onset of sensory and motor blockade,duration of blockade in supraclavicular brachial plexus block. |