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CTRI Number  CTRI/2025/11/098120 [Registered on: 26/11/2025] Trial Registered Prospectively
Last Modified On: 25/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing Ketoprofen and Diclofenac for Post-Surgery Pain Management 
Scientific Title of Study   Comparative evaluation of analgesic efficacy of transdermal ketoprofen patch versus transdermal diclofenac patch as postoperative pain management in lower limb surgeries: A prospective, comparative, clinical study 
Trial Acronym  Nil  
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Saloni Shah  
Designation  Resident Doctor 
Affiliation  Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre 
Address  Anaesthesia Department, General Ot Complex ,2nd Floor, Dhiraj Hospital , Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre , Waghodiya, Piparia ,Vadodara,GUJARAT,391760 India Vadodara

Vadodara
GUJARAT
391760
India 
Phone  8485962408  
Fax    
Email  saloni24shah@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Amit P Chauhan 
Designation  Professor 
Affiliation  Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre 
Address  Anaesthesia Department, General Ot Complex ,2nd Floor, Dhiraj Hospital , Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre , Waghodiya, Piparia ,Vadodara,GUJARAT,391760 India Vadodara

Vadodara
GUJARAT
391760
India 
Phone  9426368170  
Fax    
Email  dramitchauhan85@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Amit P Chauhan 
Designation  Professor 
Affiliation  Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre 
Address  Anaesthesia Department, General Ot Complex ,2nd Floor, Dhiraj Hospital , Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre , Waghodiya, Piparia ,Vadodara,GUJARAT,391760 India Vadodara

Vadodara
GUJARAT
391760
India 
Phone  9426368170  
Fax    
Email  dramitchauhan85@gmail.com  
 
Source of Monetary or Material Support  
Smt.B.K.Shah Medical College and research centre  
 
Primary Sponsor  
Name  Smt Bhikiben Kanjibhai Shah Medical Institute and Research Centre 
Address  Waghodia , Pipariya, Vadodara, Gujarat , India Pincode- 391760 
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 Saloni shah  Smt Bhikiben Kanjibhai Shah Medical Institute and Research Centre   Anaesthesia Department, General Ot Complex ,2nd Floor, Dhiraj Hospital , Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre , Waghodiya, Piparia ,Vadodara,GUJARAT,391760
Vadodara
GUJARAT 		 8485962408

saloni24shah@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sumandeep Vidyapeeth Institutional Ethical Committee  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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Diclofenac patch   Analgesic efficacy for postoperative pain in lower limb surgery 
Intervention  Ketoprofen patch  Pain assessment post lowerlimb surgery patients 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  -patient giving consent
-patient posted for major lower limb surgery
-under ASA I,II grade 
 
ExclusionCriteria 
Details  -patient not giving consent
-patient having limb defects
-pregnant and lactating women
- history of allergy to drugs 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the efficacy of transdermal ketoprofen patch vs transdermal diclofenac patch for postoperative pain in lower limb surgery   0 to 24hours 
 
Secondary Outcome  
Outcome  TimePoints 
If additional analgesia is required within 24hrs postoperatively  0 hrs to 24hrs  
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   10/12/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  10/12/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="9"
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  

This study aimed to compare the analgesic efficacy and safety profile of transdermal ketoprofen and diclofenac patches in the management of postoperative pain following lower limb surgeries. It was designed as a prospective, comparative clinical study involving postoperative patients who received either a ketoprofen or diclofenac transdermal patch. Pain intensity was assessed at regular intervals using standardized pain scales, and any adverse effects were recorded. The findings evaluated which patch provided superior or longer-lasting analgesia with fewer side effects. The study sought to determine the more effective and safer transdermal NSAID option for postoperative pain relief.

 
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