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
|
|
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
|
|
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. |