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CTRI Number  CTRI/2024/02/063154 [Registered on: 26/02/2024] Trial Registered Prospectively
Last Modified On: 21/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   The effect of transdermal patch of ketoprofen and diclofenac in laproscopic cholecystectomy surgery 
Scientific Title of Study   Efficacy of transdermal ketoprofen patch vs diclofenac patch in laproscopic cholecystectomy: A Randomised controlled Trial 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Swarna Rajhans 
Designation  Junior Resident 
Affiliation  Rohilkhand medical college and hospital 
Address  Department of Anaesthesia, Rohilkhand medical college and Hospital, Bereilly

Bareilly
UTTAR PRADESH
243006
India 
Phone  8210742950  
Fax    
Email  swarnarajhans@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Neeharika Arora 
Designation  Professor 
Affiliation  Rohilkhand medical college and hospital 
Address  Department of Anaesthesiology Room no-2062-D Rohilkhand medical college and hospial,pilibhit bypass road, bareilly

Bareilly
UTTAR PRADESH
243006
India 
Phone  8077104070  
Fax    
Email  docneehars@gmail.com  
 
Details of Contact Person
Public Query  
Name  Neeharika Arora 
Designation  Professor 
Affiliation  Rohilkhand medical college and hospital 
Address  Department of Anaesthesiology Room no-2062-D Rohilkhand medical college and hospial,pilibhit bypass road, bareilly

Bareilly
UTTAR PRADESH
243006
India 
Phone  8077104070  
Fax    
Email  docneehars@gmail.com  
 
Source of Monetary or Material Support  
OT complex, Department of Anaesthesia 
 
Primary Sponsor  
Name  Department of Anaesthesia 
Address  Rohilkhand medical college and hospial,pilibhit bypass road, bareilly 
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 Neeharika Arora  OT complex, Department of Anaesthesia  Rohilkhand Medical College And Hospital-243006
Bareilly
UTTAR PRADESH 		 8077104070

docneehars@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee,RMCH,Bareilly,U.p.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  diclofenac patch  Each patch of 50cm2 contains 100mg diclofenac were given to patients. 
Intervention  ketoprofen patch  Each patch of 70cm2 contains 30mg of ketoprofen were given to patients. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA grade I and II,
weight between 40 and 80 kgs 
 
ExclusionCriteria 
Details  Patients with history of:
-Dermatitis
-Hypersensitivity reaction
-Bleeding disorder
-Neurological disorder
-Renal disorder
-Psychiatric disease
-Hepatic disease
-Renal disease
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1)In the immediate post operative phase, pain severity was recorded using ‘the 10-point’ Visual Analogue Scale(VAS).
2)The effect of pain on quality of life and assess the quality of pain relief is studied using Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R).  		 1)To evaluate the effectiveness of pain treatment in the first 24 hours following surgery using The Revised American Pain Society Patient Outcome Questionnaire will be used (APS-POQ-R).
2)To analyse 10-point Visual Analogue Scale (VAS) to measure pain intensity at immediate post operative,2, 4, 6, 12 and 24 hours. 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="76"
Sample Size from India="76" 
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)   02/03/2024 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
•Thorough pre-anaesthetic check-up will be done a day before surgery and informed written consent for participation in the study will be taken. CBC, urine routine and microscopy, blood urea nitrogen, serum creatinine, fasting blood and post-meal blood sugar, an x-ray of the chest, a PA view, and an ECG are all part of standard investigations that will be carried out.
•The patients will be randomly divided among two groups: Group “1” and “2”.

   - In group 1, Patients will be given a transdermal patch containing sodium diclofenac (each patch of 75cm2 contains  200mg)

    -In group 2, Ketoprofen transdermal patches will be given to patients (each patch of 70cm2 contains 30mg).

•Before surgery, the patient will be maintained NPO for eight hours. The patch application site will be thoroughly washed with clear water before being dried. The patch will be applied two hours before to induction of anaesthesia on intact, clean, dry, and hairless skin. When entering the preoperative room, the patient’s Systolic as well as Diastolic blood pressure, and Heart rate will be recorded.
• In the immediate post operative phase, pain severity will be recorded using ‘the 10-point’ Visual Analogue Scale(VAS). Patient will be asked to score the intensity of pain at immediate post operative period,2,4,6,12 and 24 hourly. The duration of post operative analgesia will be calculated till the consumption of the first rescue analgesic. Tramadol hydrochloride 2mg/kg will be used as a rescue analgesic whenever the patient scored pain (VAS>4).•To assess the quality of pain , The Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R) will be used to evaluate the effectiveness of pain treatment in the first 24 hours following surgery.
 We will also compare incidence of side effects such as erythema, pruritus, gastritis, nausea, vomiting, and dizziness.
 
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