| CTRI Number |
CTRI/2021/03/031877 [Registered on: 10/03/2021] Trial Registered Prospectively |
| Last Modified On: |
09/03/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing the effect of Transdermal Fentanyl patch with Buprenorphine patch after abdominal surgeries for pain relief |
|
Scientific Title of Study
|
comparison of efficacy of transdermal fentanylpatch with buprenorphine patch post-operatively pain relief after abdominal surgeries |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Poorvi Chadha |
| Designation |
JR-3 |
| Affiliation |
mahatma gandhi medical college and hospital |
| Address |
Department of Anaesthesia, ot- 2nd floor, Mahatma Gandhi medical college and hospital, Sitapura , Jaipur
Mahatma Gandhi medical college and hospital, Sitapura , Jaipur
Jaipur
RAJASTHAN
302022
India |
| Phone |
8650598611 |
| Fax |
|
| Email |
poorvi_chadha@yahoo.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kalpana Verma |
| Designation |
Associate Profeessor |
| Affiliation |
mahatma gandhi medical college and hospital |
| Address |
Department of Anaesthesia, ot- 2nd floor ,Mahatma Gandhi medical college and hospital, Sitapura , Jaipur
Mahatma Gandhi medical college and hospital, Sitapura , Jaipur
Jaipur
RAJASTHAN
302022
India |
| Phone |
9588079916 |
| Fax |
|
| Email |
kalpana2007.kv@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kalpana Verma |
| Designation |
Associate Professor |
| Affiliation |
mahatma gandhi medical college and hospital |
| Address |
Department of Anaesthesia, ot -2nd floor ,Mahatma Gandhi medical college and hospital, Sitapura , Jaipur
Mahatma Gandhi medical college and hospital, Sitapura , Jaipur
Jaipur
RAJASTHAN
302022
India |
| Phone |
9588079916 |
| Fax |
|
| Email |
kalpana2007.kv@gmail.com |
|
|
Source of Monetary or Material Support
|
| mahatma ganghi medical college and hospital |
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
nil |
| Type of Sponsor |
Other [nil] |
|
|
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 Poorvi Chadha |
mahatma gandhi medical college and hospital |
Department of anesthesia and critical care, ot -2nd floor,Mahatma Gandhi medical college and hospital, Sitapura , Jaipur
Jaipur
RAJASTHAN |
8650598611
poorvi_chadha@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC |
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 |
buprenorphine patch |
12 hr before the sugery |
| Intervention |
fentanyl and buprenorphine patch applied |
both patches before the day of surgery |
| Comparator Agent |
fentanyl patch |
12 hr before the sugery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
ASA I/II
PATIENTS UNDERGOING ABDOMINAL SURGERIES
GIVING CONSENT WILLINGLY |
|
| ExclusionCriteria |
| Details |
ASA III/IV
PATIENT REFUSAL
OPIOID DEPENDENT
PATIENT ON ANTI-DEPRESSANTS
MORBIDLY OBESE
ALLERGIC TO STUDY MATERIAL |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Post operative pain relief |
post operative pain relief in 12-24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| sedation score was recorded |
48 hour post -operatively |
|
|
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)
|
16/03/2021 |
| 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="1"
Days="1" |
|
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)?
Response - NO
|
|
Brief Summary
|
we are comparing the efficacy of transdermal fentanyl and buprenorphine patch for post-operative pain relief in patients undergoing major abdominal surgeries. And found that fentanyl and buprenorphine patch have insignificant results |