CTRI Number |
CTRI/2023/02/050112 [Registered on: 27/02/2023] Trial Registered Prospectively |
Last Modified On: |
24/02/2023 |
Post Graduate Thesis |
No |
Type of Trial |
Observational |
Type of Study
|
Cross Sectional Study |
Study Design |
Other |
Public Title of Study
|
Study of transdermal drug patches used for acute pain in major public hospital |
Scientific Title of Study
|
An observational study to evaluate the use of transdermal patches for acute pain in surgery wards in a tertiary care centre |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Sweta Salgaonkar |
Designation |
Professor |
Affiliation |
Seth GSMC and KEM Hospital, Mumbai |
Address |
Department of Anaethesia
Seth GSMC and KEM hospital
Mumbai MAHARASHTRA 400012 India |
Phone |
|
Fax |
|
Email |
swetavs@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Sweta Salgaonkar |
Designation |
Professor |
Affiliation |
Seth GSMC and KEM Hospital, Mumbai |
Address |
Department of Anaethesia
Seth GSMC and KEM hospital
Mumbai MAHARASHTRA 400012 India |
Phone |
|
Fax |
|
Email |
swetavs@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Sweta Salgaonkar |
Designation |
Professor |
Affiliation |
Seth GSMC and KEM hospital, Mumbai |
Address |
Department of Anaethesia
Seth GSMC and KEM hospital
Mumbai MAHARASHTRA 400012 India |
Phone |
|
Fax |
|
Email |
swetavs@gmail.com |
|
Source of Monetary or Material Support
|
Seth GSMC and KEM Hospital, Mumbai |
|
Primary Sponsor
|
Name |
Seth GSMC and KEM Hospital |
Address |
Seth GSMC and KEM Hospital, Acharya Dhonde Marg, Parel East, 400012 |
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 Dhwani Walavalkar |
Seth GSMC & KEMH |
Ward 5,6,7,8, department of anaesthesia, First floor, old building, Seth GSMC and KEM hospital,PAREL
EAST Mumbai MAHARASHTRA |
09930826696
dhwani.walavalkar@yahoo.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
IEC 3 KEM hospital |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: R688||Other general symptoms and signs, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
observational study |
observational study |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
70.00 Year(s) |
Gender |
Both |
Details |
all patient having transdermal patches who are willing to participate will be included |
|
ExclusionCriteria |
Details |
Not willing to give consent
Psychiatric disorder |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Most common transdermal patch, percentage of pain relief, type of pain |
Baseline, 1 month, 6 months |
|
Secondary Outcome
|
Outcome |
TimePoints |
to decrease use of transdermal patches in acute pain for unindicated reasons |
2 years |
|
Target Sample Size
|
Total Sample Size="150" Sample Size from India="150"
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)
|
28/02/2023 |
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
|
None yet |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Acute pain is a complex process involving activation of nociceptors, chemical mediators and inflammation. In the surgical setting acute pain most commonly occurs due to trauma, disease pathology such as acute pancreatitis or post operatively. Medications can be used to target each of the key elements within the pain pathway and eliminate or reduce the sensation of pain. Transdermal analgesics are now being used in many areas of pain management and by many different patient groups. In the management of acute pain, the pain relief patch has two roles: prevention and treatment. Transdermal delivery of opioids has been used for many years, but has not been recommended for use in acute pain due to delayed onset of action and risks of toxicity. Elimination half-life of transdermal opioids can be up to 27 hours, thus patients who experience side effects, especially respiratory depression, need to be monitored and supported for a full day after discontinuing therapy. Yet, transdermal patches are routinely used in the surgical wards of our institute for acute pain management. This study is being conducted to assess the prevalence of use of transdermal patches for management of acute pain and to assess the patients knowledge and compliance with respect to transdermal patches. |