| CTRI Number |
CTRI/2021/08/035486 [Registered on: 06/08/2021] Trial Registered Prospectively |
| Last Modified On: |
30/07/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare the effectiveness of transdermal buprenorphine and fentanyl patch for post operative pain control in abdominal surgery. |
|
Scientific Title of Study
|
Comparative study of transdermal buprenorphine and fentanyl patch for post operative analgesia in abdominal surgery under general anaesthesia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Cheraj Laxmi Angom |
| Designation |
Post graduate trainee |
| Affiliation |
Regional institute of medical sciences, imphal |
| Address |
Department of anaesthesiology, Regional institute of medical sciences, lamphelpat,imphal west
Imphal West
MANIPUR
795004
India |
| Phone |
8837261751 |
| Fax |
|
| Email |
cheraj29laxmi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kh Maniram Singh |
| Designation |
Professor |
| Affiliation |
Regional institute of medical sciences, imphal |
| Address |
Department of anaesthesiology, Regional institute of medical sciences, lamphelpat,imphal west
Imphal West
MANIPUR
795004
India |
| Phone |
8259055986 |
| Fax |
|
| Email |
drmram6@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kh Maniram Singh |
| Designation |
Professor |
| Affiliation |
Regional institute of medical sciences, imphal |
| Address |
Department of anaesthesiology, Regional institute of medical sciences, lamphelpat,imphal west
Imphal West
MANIPUR
795004
India |
| Phone |
8259055986 |
| Fax |
|
| Email |
drmram6@gmail.com |
|
|
Source of Monetary or Material Support
|
| Regional institute of medical sciences, imphal |
|
|
Primary Sponsor
|
| Name |
Cheraj Laxmi Angom |
| Address |
Department of anaesthesiology, Regional institute of medical sciences, imphal west 795004 |
| 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 |
| Cheraj Laxmi Angom |
Regional institute of medical sciences, imphal |
Department of anesthesiology, regional institute of medical sciences, lamphelpat imphal west,795004
Imphal West
MANIPUR |
8837261751
cheraj29laxmi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research Ethics Board, RIMS, imphal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Transdermal buprenorphine patch(10ug/hr) |
Transdermal buprenorphine patch will be applied 12 hrs before surgery on the hairless area of the right upper arm. |
| Comparator Agent |
Transdermal fentanyl patch (25ug/hr) |
Transdermal fentanyl patch will be applied 12 hrs before surgery on the hairless area of the right upper arm. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient scheduled to undergo elective abdominal surgery under general anaesthesia with ASA I and II physical status |
|
| ExclusionCriteria |
| Details |
1)History of skin allergy
2) pregnant patient |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Post operative analgesia |
At the end of surgery,1hr,2hr,4hr,6hr,12hr after surgery,2nd and 3rd day of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
10/08/2021 |
| 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="10"
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
|
A randomised single blinded study to compare the efficacy of transdermal buprenorphine and fentanyl patch for post operative analgesia in abdominal surgery under general anaesthesia,to be conducted in the department of anaesthesiology, Regional institute of medical sciences, imphal in 80 patients within 20-60 yrs of age with ASA grade I and II. The transdermal buprenorphine and fentanyl patch will be applied 12 hrs before surgery on the hairless area of right upper arm and will be followed up for post operative analgesia at the end of surgery,1hr,2hr,4hr,6hr,12hr after surgery,2nd and 3rd day of surgery
|