跳至主要内容
临床试验/CTRI/2022/12/047868
CTRI/2022/12/047868尚未招募Phase 3 4

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

未提供1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2022年5月12日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
入组人数
70
试验地点
1
主要终点
Postoperative pain assessment using Verbal Rating Scale and Numerical Rating Scale

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

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

排除标准

  • 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
  • Pregnant and Lactating mothers
  • Subjects with hypersensitivity to the study medications
  • 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.

结局指标

主要结局

Postoperative pain assessment using Verbal Rating Scale and Numerical Rating Scale

时间窗: 0hour, 4hour, 8hour, 12hour and 24hour postoperative period

次要结局

  • Need for rescue analgesic(Within the first 24hour postoperative period)
  • Timing of rescue analgesic administration(From the time of surgery)

研究者

发起方
未提供

研究点 (1)

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