| CTRI Number |
CTRI/2020/10/028481 [Registered on: 20/10/2020] Trial Registered Prospectively |
| Last Modified On: |
20/10/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the efficacy of pain relief between patch and epidural in renal surgery |
|
Scientific Title of Study
|
To compare and evaluate the efficacy of
transdermal buprenorphine patch (10 mg) with continuous epidural infusion for post operative analgesia in renal surgeries. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
APRAJITA SHARMA |
| Designation |
JR Anaesthesia |
| Affiliation |
Indra Gandhi Medical College Shimla |
| Address |
Dr.Aprajita Sharma, junior resident, Dept of Anaesthesia,IGMC Shimla
Dept of Anaesthesia, IGMC Shimla
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
8219200797 |
| Fax |
|
| Email |
appysharma3115@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
RAJESH VERMA |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
Indra Gandhi Medical College Shimla |
| Address |
Dr.Rajesh Verma,Associate Professor,Dept.Of Anaesthesia, IGMC Shimla
Dept of Anaesthesia,IGMC Shimla, HP
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
9418077248 |
| Fax |
|
| Email |
drrajeshkverma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
APRAJITA SHARMA |
| Designation |
JR Anaesthesia |
| Affiliation |
Indra Gandhi Medical College Shimla |
| Address |
Dr.Aprajita Sharma,Dept of Anaesthesia, IGMC Shimla
Dept of Anaesthesia,IGMC shimla
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
8219200797 |
| Fax |
|
| Email |
appysharma3115@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Aprajita Sharma |
| Address |
JR ANAESTHESIA ,IGMC SHIMLA |
| Type of Sponsor |
Other [self] |
|
|
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 |
| APRAJITA |
IGMC SHIMLA |
Urology OT,OT 3, Department of Anaesthesia, IGMC Shimla
Shimla
HIMACHAL PRADESH |
8219200797
appysharma3115@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee IGMC, Shimla |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N202||Calculus of kidney with calculus of ureter, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Buprenorphine transdermal patch |
10 mg patch to be applied transdermally for 48 hrs |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 and ASA 2
Weight 40- 70kg |
|
| ExclusionCriteria |
| Details |
allergic to buprenorphine
allergic to opoids
skin allergies |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| post operative analgesic efficacy |
post operative analgesic efficacy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| adverse effects if any |
till 48 hrs |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
01/11/2020 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
We shall be comparing post operative analgesic efficacy of trandermal buprenorphine patch with continuous epidural infusion in renal surgeries as these surgeries are associated with moderate to severe post operative pain. |