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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

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

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/12/047868
Enrollment
70
Registered
2022-12-05
Start date
Unknown
Completion date
Unknown
Last updated
2023-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G891- Acute pain, not elsewhere classified Health Condition 2: M968- Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified

Interventions

Intervention1: 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 perio

Sponsors

nil
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
Postoperative pain assessment using Verbal Rating Scale and Numerical Rating ScaleTimepoint: 0hour, 4hour, 8hour, 12hour and 24hour postoperative period

Secondary

MeasureTime frame
Need for rescue analgesicTimepoint: Within the first 24hour postoperative period;Timing of rescue analgesic administrationTimepoint: From the time of surgery

Countries

India

Contacts

Public ContactDr Chethan B

Department of Pharmacology, Kempegowda Institute of Medical Sciences, Bangalore

drpriyanka110@gmail.com9844093100

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026