| CTRI Number |
CTRI/2019/09/021103 [Registered on: 06/09/2019] Trial Registered Prospectively |
| Last Modified On: |
03/09/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
A comparison between two drugs bupivacaine and ropivacaine both with buprenorphine for patients coming lower limb operation. |
|
Scientific Title of Study
|
A Comparitive study of epidural 0.5% bupivacaine with buprenorphine and 0.5% ropivacaine with buprenorphine for elective lower limb surgeries. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nabeela Basri |
| Designation |
Post graduate |
| Affiliation |
KIMS hospital, VV puram, Bangalore |
| Address |
Room no 412D, KIMS resident quarters, KIMS hospital, VV puram, Bangalore.
Bangalore
KARNATAKA
560004
India |
| Phone |
9448246845 |
| Fax |
|
| Email |
nabeelabasrir@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ashwini A |
| Designation |
Associate Professor |
| Affiliation |
KIMS hospital VV puram, Bangalore |
| Address |
Department of anesthesiology, KIMS hospital, VV puram, Bangalore.
Bangalore
KARNATAKA
560004
India |
| Phone |
|
| Fax |
|
| Email |
dr.ashwinivijay.a@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nabeela Basri |
| Designation |
post graduate |
| Affiliation |
KIMS hospital VV puram, Bangalore |
| Address |
Room no 412D, KIMS resident quarters, KIMS hospital, VV puram, Bangalore.
Bangalore
KARNATAKA
560004
India |
| Phone |
9448246845 |
| Fax |
|
| Email |
nabeelabasrir@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.Nabeela basri KIMS hospital,Banglore |
|
|
Primary Sponsor
|
| Name |
Dr Nabeela basri self |
| Address |
Room no.412 D kims resident quatres ,KIMS hospital, VV puram Bangalore. |
| 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 |
| Nabeela |
KIMS hospital |
KIMS Hospital,VV Puram,Bangalore ,560004
Bangalore
KARNATAKA |
9448246845
nabeelabasrir@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: M849||Disorder of continuity of bone, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
A study of 0.5% bupivacaine with buprenorphine in epidural for lower limb surgeries |
Comparison of 14.5 ml of Bupivacaine with 150 microgram of Buprenorphine and 14.5 ml of Ropivacaine with 150 microgram |
| Comparator Agent |
A study of 0.5% ropivacaine with buprenorphine in epidural for lower limb surgeries. |
patients coming for lower limb surgeries |
| Intervention |
comparative astudy of epidural 0.5% bupivacaine with buoprenorphine and 0.5% ropivacaine with buprenorphine for elective lower limb surgeries. |
intervention done in patients coming for lower limb surgeries. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
American society of anaesthesiology status 1 and 2
patient posted for elective lower limb surgeries |
|
| ExclusionCriteria |
| Details |
Coagulopathy and patients on anticoagulants.
allergic to local anaesthetic agents.
neurological deformities
pregnancy an lactation. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 0.5% Ropivacaine with buprenorphine has a better outcome compared to 0.5% bupivacaine withbuprenorphine. |
30/8/2020 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
27/12/2019 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is to compare two drugs , 0.5% bupivacaine with 150 microgram of buprenorphine and 0.5% ropivacaine with 150 microgram of buprenorphine in sole epidural for lower limb surgeries as sole epidural provides better intraoperative hemodynamic stability compare to spinal anaesthsia |