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

Phase 3

Not yet recruiting

Conditions: Acute pain, not elsewhere classified, (2) ICD-10 Condition: M968||Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified,

Registration Number: CTRI/2022/12/047868

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 70

Inclusion Criteria

Subjects willing to give written informed consent.
Adults above 18 years and below 65 years of age of either gender.

Exclusion Criteria

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.
Subjects operated under general anaesthesia.
Subjects with contraindications to regional block.
Subjects with history of peripheral neuropathy and pre-existing nerve damage in the operative arm.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Postoperative pain assessment using Verbal Rating Scale and Numerical Rating Scale	0hour, 4hour, 8hour, 12hour and 24hour postoperative period

Secondary Outcome Measures

Name	Time	Method
Timing of rescue analgesic administration	From the time of surgery
Need for rescue analgesic	Within the first 24hour postoperative period

Trial Locations

Locations (1): Kempegowda Institute of Medical Sciences Hospital and Research Centre
🇮🇳
Bangalore, KARNATAKA, India
Kempegowda Institute of Medical Sciences Hospital and Research Centre
🇮🇳Bangalore, KARNATAKA, India
Dr Chethan B
Principal investigator
9066727063
chethan.bovi@gmail.com