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CTRI Number  CTRI/2022/12/047868 [Registered on: 05/12/2022] Trial Registered Prospectively
Last Modified On: 28/11/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trial to study the effects of two drugs, Diclofenac and Ketoprofen, which are used to reduce pain in postoperative upper limb orthopedic surgeries 
Scientific Title of Study   A PROSPECTIVE RANDOMISED COMPARATIVE STUDY TO EVALUATE EFFICACY, TOLERABILITY AND COST-EFFECTIVENESS OF TRANSDERMAL DICLOFENAC AND KETOPROFEN PATCHES FOR POSTOPERATIVE ANALGESIA IN UPPER LIMB FRACTURE FIXATION SURGERIES IN A TERTIARY CARE HOSPITAL 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Chethan B 
Designation  Postgraduate 
Affiliation  Kempegowda Institute of Medical Sciences, Bangalore 
Address  Kempegowda Institute of Medical Sciences, Department of Pharmacology, 30th main road, Siddanna layout, Banashankari 2nd stage, Banashankari, Bangalore

Bangalore
KARNATAKA
560070
India 
Phone  09066727063  
Fax    
Email  chethan.bovi@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Priyanka S 
Designation  Assistant Professor 
Affiliation  Department of Pharmacology, Kempegowda Institute of Medical Sciences, Bangalore 
Address  Kempegowda Institute of Medical Sciences, Department of Pharmacology, 30th main road, Siddanna Layout, Banashankari 2nd stage, Banashankari, Bangalore

Bangalore
KARNATAKA
560070
India 
Phone  9844093100  
Fax    
Email  drpriyanka110@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Chethan B 
Designation  Postgraduate 
Affiliation  Kempegowda Institute of Medical Sciences, Bangalore 
Address  Kempegowda Institute of Medical Sciences, Department of Pharmacology, 30th main road, Siddanna layout, Banashankari 2nd stage, Banashankari, Bangalore

Bangalore
KARNATAKA
560070
India 
Phone  09066727063  
Fax    
Email  chethan.bovi@gmail.com  
 
Source of Monetary or Material Support  
Kempegowda Institute of Medical Sciences Hospital and Research Centre, Bangalore 
 
Primary Sponsor  
Name  nil 
Address  nil 
Type of Sponsor  Other [academic study] 
 
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 Chethan B  Kempegowda Institute of Medical Sciences Hospital and Research Centre  Department of Orthopedics, Krishna Rajendra Road, Parvathipuram, Vishweshwarapura, Shankarapura, Bengaluru-560002
Bangalore
KARNATAKA 
9066727063

chethan.bovi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of KEMPEGOWDA INSTITUTE OF MEDICAL SCIENCES, BANGALORE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G891||Acute pain, not elsewhere classified, (2) ICD-10 Condition: M968||Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Diclofenac transdermal patch  100mg single transdermal patch is applied on the non hairy part of the back of the subject and pain is assessed over the first 24 hours postoperative period 
Intervention  Ketoprofen transdermal patch  20mg single transdermal patch is applied on the non hairy part of the back of the subject and pain is assessed over the first 24 hours postoperative period.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Subjects willing to give written informed consent.
2. Adults above 18 years and below 65 years of age of either gender.
3. Subjects who are undergoing upper limb fracture fixation surgery.
 
 
ExclusionCriteria 
Details  1. Subjects having history of heart block, bronchial asthma, bleeding disorders, on anticoagulants, active peptic ulcer disease, skin diseases, liver and kidney disorders and drug/alcohol abuse
2. Pregnant and Lactating mothers
3. Subjects with hypersensitivity to the study medications
4. Subjects with poly trauma.
5. Subjects operated under general anaesthesia.
6. Subjects with contraindications to regional block.
7. Subjects with history of peripheral neuropathy and pre-existing nerve damage in the operative arm
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Postoperative pain assessment using Verbal Rating Scale and Numerical Rating Scale  0hour, 4hour, 8hour, 12hour and 24hour postoperative period 
 
Secondary Outcome  
Outcome  TimePoints 
Need for rescue analgesic   Within the first 24hour postoperative period 
Timing of rescue analgesic administration   From the time of surgery 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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 3/ Phase 4 
Date of First Enrollment (India)   05/12/2022 
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="5"
Days="30" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Post operative pain (POP) is a critical aspect after any surgery manifesting in 70-75% of patients as moderate to severe pain. Its management is an important public health concern worldwide, especially following orthopaedic surgery. The upper limb orthopaedic surgeries which include both bone and soft tissue, should have an appropriate analgesic modality to reduce delayed post operative function which increases the duration of hospital stay and occurrence of re-admission which impacts the socio-economic and quality of life of the patients.

Non-steroidal anti-inflammatory drugs (NSAIDs) are one of the commonly used drugs for POP relief throughout the world as they require less monitoring with fewer side effects. They are administered by oral, parenteral, inhalational, and transdermal routes. Transdermal patches provide prolonged and steady release of drugs with added advantage of avoiding first pass metabolism. Patient compliance is improved since it provides reduced dosage frequency with ease of administration and termination compared to oral route. Being non-invasive it allays the fear associated with parenteral routes.  They are especially useful for post-op analgesia in surgeries where tissue dissection or expected pain is moderate such as upper limb fracture fixation surgeries.

Commonly used NSAIDs in this route are diclofenac and ketoprofen. Diclofenac is a relatively nonselective inhibitor of Cyclooxygenase (COX) whereas Ketoprofen is a nonselective COX and also Lipooxygenase inhibitor. This study is conducted as there is lack of data comparing the efficacy, tolerability, and cost-effectiveness of the transdermal patches of diclofenac and ketoprofen in post operative analgesia in upper limb fracture fixation surgeries.

 
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