FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2022/12/048088 [Registered on: 14/12/2022] Trial Registered Prospectively
Last Modified On: 05/12/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Randomised control study using Diclofenac patch 
Scientific Title of Study   Efficacy of Diclofenac transdermal patch versus injectable Diclofenac in post LSCS analgesia- A comparative, double blind random controlled trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mohan Sunkad  
Designation  Emeritus Professor 
Affiliation  USM KLE IMP 
Address  KLE C C Hospital Yellur Road Belgaum
USM KLE IMP Nehru Nagar Belgaum Karnataka India
Belgaum
KARNATAKA
590005
India 
Phone  7829716240  
Fax  918312455558  
Email  msunkad@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Satish Dhamankar 
Designation  Associate Professor 
Affiliation  USM KLE IMP 
Address  KLE C C Hospital Yellur Road Belgaum
USM KLE IMP Nehru Nagar Belgaum Karnataka India
Belgaum
KARNATAKA
590005
India 
Phone  9448151441  
Fax  918312455558  
Email  drsdhamankar@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Satish Dhamankar 
Designation  Associate Professor 
Affiliation  USM KLE IMP 
Address  KLE C C Hospital Yellur Road Belgaum
USM KLE IMP Nehru Nagar Belgaum Karnataka India

KARNATAKA
590005
India 
Phone  9448151441  
Fax  918312455558  
Email  drsdhamankar@yahoo.com  
 
Source of Monetary or Material Support  
Institutional funds USM KLE IMP Nehrunagar Belgaum 
 
Primary Sponsor  
Name  Director USM KLE IMP 
Address  USM KLE IMP Nehru nagar Belgaum Karnataka India 
Type of Sponsor  Private 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 Satish Dhamankar  KLE CC Hospital Yellur Belgaum India  Department of OBG first floor post operative ward
Belgaum
KARNATAKA 		 9448151441
918312455558
drsdhamankar@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee USM KLE International Medical Programme  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O269||Pregnancy related conditions, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Patients are divided into two randomized groups In one group transdermal diclofenac patch is applied as post operation analgesia, in another group Injectable Diclofenac is given.  All patients undergoing caesarian delivery divided into two randomized groups In one group tansdermal diclofenac patch and other comparator group injectable diclofenac given for analgesia Visual analogue scale used to assess pain 
Comparator Agent  Transdermal diclofenac patch for postoperative analgesia after caesarin delivery assessed using visual analogue scale  The transdermal diclofenac patch is compared with injectable diclofenac in two randomized group of patients assessed using visual analogue scale 
Intervention  Transdermal Diclofenac patch is applied for post operation analgesia after Caesarian delivery  The participants are divided into two symmetrical groups one group will receive transdermal diclofenac patch for analgesia while other group injectable diclofenac pain relief in two groups assessed using visual analogue scale and compared 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  All pregnant women undergoing Lower Segment Caesarian Section in the age range of 18 to 40 years healthy normal pregnancy completed 38 weeks duration no or mild systemic diseases satisfying to American Society of Anesthesiologists Group I and II who are willing to participate are included in the study 
 
ExclusionCriteria 
Details  Patients unsuitable for spinal anaesthesia, history of allergy to analgesic drugs, women with bowel disorders like ulcers inflammatory bowel disease ASA group III and IV and not willing to participate were excluded from the study 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Visual analogue scale score
No Pain Satisfactory post operation analgesia 		 at four hours after Caesarian delivery and there after interval of four hours for 48 hours 
 
Secondary Outcome  
Outcome  TimePoints 
The first four post operation days following Caesarian delivery pain free, visual analogue score 1-3 mm  Following caesarian delivery mothers do feel pain free at third and fourth days 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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)   01/01/2023 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not applicable 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Data are available indefinitely at (Link to be included dsmohan_s@rediffmail.com).

  6. For how long will this data be available start date provided 31-07-2023 and end date provided 31-12-2023?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - No additional information
Brief Summary   Title Efficacy of Transdermal Patch of Diclofenac Over Injectables As Post Operative Analgesia

The drug Diclofenac is tried tested and approved for use all over the world in 1993 The caesarean deliveries are quite common in obstetrics practice  An adequate relief after caesarean section eliminates the bad effects of pain on various organs in the mother and encourages early movement and better care of the baby It is agreed that the choice of analgesia should be effective and safe without  interfering the mothers ability to take care of her baby along with no  adverse effects to the baby Oral and injectable  non steroidal anti inflamatory drugs NSAIDS have been used widely for postoperative pain relief The Oral administration is the prefered choice in daily practice but its high first pass metabolism becomes impractical before and after surgery The innovative drug delivery systems are being available with the understanding of pain pathophysiology and treatment new routes of drug delivery are being used with the objective of attempting to block pain at peripheral sites with maximum active drug and minimal systemic effects The result is Topical Transdermal preparations in this direction

However there is not enough literature available on the application of transdermal patch as post operative analgesia in LSCS cases

This is the focus of our study We would compare the analgesia obtained between transdermal diclofenac patch with intramuscular diclofenac injection The drug Diclofenac was invented in 1965 by Ciba Geigy and put into medical use since 1988 It can be used by various routes like oral intramuscular Intravenous transdermal and rectal Following Caesarian section there is need for analgesia and generally injectable form is being commonly practiced and transdermal patch rarely used

Therefore the need of the present study is to establish the use of diclofenac transdermal patch as a potentially effective analgesia post operatively in LSCS cases We adhere to all the standard protocols concerning use of medicine trial in patients

 
Close