FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
Close