| CTRI Number |
CTRI/2021/09/036226 [Registered on: 03/09/2021] Trial Registered Prospectively |
| Last Modified On: |
01/09/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
1.To determine the difference in VAS score between both the groups.
2.To determine the difference in time for need of first rescue analgesia and total number of doses of rescue analgesic required during first 72 hours postoperatively between both the groups. |
|
Scientific Title of Study
|
Comparison of postoperative analgesia of intravenous tramadol vs transdermal buprenorphine patch in aortofemoral graft surgery - A randomized interventional study at SMS Medical College, Jaipur during 2020-21 |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR REEMA MEENA |
| Designation |
SENIOR PROFESSOR |
| Affiliation |
SMS Medical College Jaipur |
| Address |
Department of Anaesthesiology SMS Medical College Jaipur Rajasthan 302004
Jaipur
RAJASTHAN
302004
India |
| Phone |
9414398827 |
| Fax |
|
| Email |
reemadrrn@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR REEMA MEENA |
| Designation |
SENIOR PROFESSOR |
| Affiliation |
SMS Medical College Jaipur |
| Address |
Department of Anaesthesiology SMS Medical College Jaipur Rajasthan 302004
Jaipur
RAJASTHAN
302004
India |
| Phone |
9414398827 |
| Fax |
|
| Email |
reemadrrn@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ASHISH KUMAR SHARMA |
| Designation |
Junior Resident |
| Affiliation |
SMS Medical college ,Jaipur |
| Address |
JLN MARG, ADHARSH NAGAR, JAIPUR.
Jaipur, RAJASTHAN
302004
India
Jaipur
RAJASTHAN
303004
India |
| Phone |
7014501117 |
| Fax |
|
| Email |
ashish3903sharma@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology, Sawai Man Singh Medical College And Attached Hospitals,
Jaipur. |
|
|
Primary Sponsor
|
| Name |
Sawai Man Singh Medical College And Attached Hospitals |
| Address |
JLN Marg, Adarsh Nagar, Jaipur |
| Type of Sponsor |
Government 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 Ashish Kumar Sharma |
SMS MEDICAL COLLEGE |
Department of
Anesthesiology,
Dhanvantri building ,1st
floor, ADARSH
NAGAR,JAIPUR. Jaipur
RAJASTHAN
Jaipur
RAJASTHAN
Jaipur
RAJASTHAN |
7014501117
ashish3903sharma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMS Medical College and Attached Hospital, Jaipur |
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 |
| Comparator Agent |
Intravenous Tramadol 100 mg |
Intravenous Tramadol 100 mg loading followed by 50mg 6 hourly |
| Intervention |
Transdermal Buprenorphine patch of 10 mg |
Transdermal Buprenorphine patch of 10 mg with a delivery rate of 10 ug/hour |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients undergoing aorto-femoral graft surgery
2.Patient willing to give written informed consent
3.Patient of either sex
4.Weighing 40 to 70 kg –BMI<40kg/m2 |
|
| ExclusionCriteria |
| Details |
1.Patient refusal
2.known or admitted alcohol or drug abusers
3.Allergic to drugs involved in study
4.Patient taking any drug that have interaction with tramadol and Buprenorphine
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To determine the difference in VAS score between both the groups.
2.To determine the difference in time for need of first rescue analgesia and total number of doses of rescue analgesic required during first 72 hours postoperatively between both the groups.
|
72 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To determine the difference in sedation score in both the groups
2.To assess and compare Hemodynamic parameters: (Heart Rate; Mean Blood Pressure; Systolic Blood Pressure; Diastolic Blood Pressure),.
3.To determine the difference in percentage of cases who develop side effects ( if any)in both groups in first 72 hours
|
72 hours |
|
|
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)
|
06/09/2021 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
To compare transdermal buprenorphine patch versus intravenous tramadol for post operative pain relief in aortofemoral graft surgery. |