| CTRI Number |
CTRI/2019/03/018245 [Registered on: 25/03/2019] Trial Registered Prospectively |
| Last Modified On: |
21/03/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of the effectiveness of Transdermal opioids for prevention of Chronic Pain after Surgery in Cancer Patients |
|
Scientific Title of Study
|
Comparison of the efficacy and safety of Transdermal Fentanyl Versus Transdermal Buprenorphine for prevention of Chronic Persistent Post Surgical Pain in Head and Neck Cancer Patients : A Randomized, Single-Blinded, Pilot Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aakanksha Bahl |
| Designation |
Post graduate resident |
| Affiliation |
University College of Medical Sciences and GTB |
| Address |
Dept of Anaesthesiology and Critical Care.
University College of Medical Sciences,GTB Hospital
East
DELHI
110095
India |
| Phone |
9582146662 |
| Fax |
|
| Email |
akkibahl91@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Aakanksha Bahl |
| Designation |
Post graduate resident |
| Affiliation |
University College of Medical Sciences and GTB |
| Address |
Dept of Anaesthesiology and Critical Care.
University College of Medical Sciences,GTB Hospital
East
DELHI
110095
India |
| Phone |
9582146662 |
| Fax |
|
| Email |
akkibahl91@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Geetanjali T Chilkoti |
| Designation |
Professor |
| Affiliation |
University College of Medical sciences |
| Address |
Dept of Anaesthesiology and Critical Care,
University College of Medical Sciences, GTB Hospital
East
DELHI
110095
India |
| Phone |
9711210772 |
| Fax |
|
| Email |
geetanjalidr@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| University College of Medical Sciences and GTB Hospital |
|
|
Primary Sponsor
|
| Name |
University College of Medical Sciences |
| Address |
2nd floor, department of Anaesthesiology and Critical Care |
| 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 |
| Aakanksha Bahl |
University College of Medical Sciences and GTB Hospital |
Anaesthesia office,2nd floor, Dept. of Anaesthesia, UCMS and GTB hospital
East
DELHI |
9582146662
akkibahl91@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe-Human |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C148||Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group-TDB |
Transdermal Buprenorphine patch dose of 10 microgram will be applied on skin on post operative day 6 and followed on 1st , 2nd, 4th, 6th and 8th week post operatively for total duration of 3 months. |
| Comparator Agent |
Group-TDF |
Transdermal Fentanyl patch of dose 50 microgram will be applied on skin on post operative day 6 and followed on 1st , 2nd, 4th, 6th and 8th week post operatively for total duration of 3 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Operated case of Head and Neck cancer, managed with Standard Postoperative Pain Management Protocol, for initial five days of post-operative period with Pain intensity ≥ 4/10 of Numerical Rating Scale-pain scale on post-operative day 6
|
|
| ExclusionCriteria |
| Details |
•Evidence of other sources of pain that may confound the diagnosis
•Recent history of any other surgery other than that for HNC
•Patients with past H/o MI, DM, pancreatitis and vasculitis.
•Patients with evidence of hepatic or renal impairment.
•Patients having allergy/intolerance to oral/parenteral/transdermal patches.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Proportion of patients achieving NRS-pain score ≤3/10 |
Proportion of patients achieving NRS-pain score ≤3/10 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparison of PDQ |
At 1st, 2nd, 4th, 6th and 8th week post patch application |
| Comparison of NPSI Score |
At 1st, 2nd, 4th, 6th and 8th week post patch application |
| Comparison of GPE Score |
At 1st, 2nd, 4th, 6th and 8th week post patch application |
| Comparison of PDI Score |
At 1st, 2nd, 4th, 6th and 8th week post patch application |
| Comparison of SF-12 score |
At 1st, 2nd, 4th, 6th and 8th week post patch application |
| Modulation in mRNA expressions of IL-6 and mTORC1 genes |
Pre-treatment and at the end of 12th week post treatment |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
31/03/2019 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NOT YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is proposed to be a one site prospective randomized study where the study participants will be divided by random allocation into two groups, one will receive treatment with TDF and one group will receive TDB pain patch application. After establishing a diagnosis of HNC, baseline assessment shall be done for pain and quality of life. After the initiation of treatment with transdermal pain patches the participants will be followed up for a period of 3 months at the designated time intervals i.e. at the end of 1st week, 2nd week, 4th week, 6th week, 8th week and 12th week. Two ml venous blood samples shall be collected from all the participants. Two such samples will be obtained as baseline and then at 12th week i.e. post commencement of the treatment with TDF and TDB. Gene expression study will be done by utilizing the real time quantitative PCR, mRNA expression of IL-6 and mTORC1 genes shall be performed. |