Pain Treatment After Joint Surgery With a Combination of Aspirin, Ketorolac, and Celecoxib.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Measuring postoperative pain using the visual analog scale for pain (VAS-P)
研究概览
简要总结
The search for new safe and effective methods of pain relief after surgery on large joints is still an urgent problem. The most optimal approach in the treatment of postoperative pain is the use of multimodal analgesia with a different mechanism of action that act on various mechanisms of pain and can include opioids, nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen, anticonvulsants, NMDA antagonists, alpha-2-agonists, and sodium and calcium channel blocking agents, as well as local anesthetics. NSAIDs are the most popular and safe means for pain relief. Therefore, a lot of efforts are aimed at increasing the effectiveness of NSAIDs use. The aim of this study was to evaluate the effectiveness of simultaneously administering two or three NSAIDs, compared to using only one NSAID, for pain relief after surgery on large joints such as hip or knee arthroplasty.
详细描述
This is 6 days, randomized, double blind, parallel group, single-center study in 105 subjects. The distribution into groups was carried out by sequentially alternating the set into 4 groups celecoxib 400 mg orally daily, aspirin 100 mg and ketorolac 90 mg orally daily, ketorolac 90 mg and celecoxib 400 mg orally daily; aspirin 200 mg, ketorolac 90 mg and celecoxib 400 mg orally daily.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patients with diagnosis of osteoarthritis of the knee or hip joint (M15.0, M16, M17) after primary knee or hip arthroplasty.
- •Informed consent.
排除标准
- •Patients who cannot cooperate with the trial.
- •Pregnant or breast feeding women,
- •Оpioid addiction,
- •Contraindication to NSAIDs (allergy to NSAID, history of ulcer and gastrointestinal bleeding, liver failure, renal failure (eGRF < 60 ml/kg/1,73m2) and chronic kidney disease 2-5, known thrombocytopenia (<100 mia/L)
研究组 & 干预措施
Drug: celecoxib
The patients received celecoxib in a dose of 400 mg orally daily. The drug was prescribed from the second day of the operation for 5 days.
干预措施: Celecoxib (Drug)
Drug: aspirin with ketorolac
The patients received aspirin in a dose of 100 mg and ketorolac 90 mg orally daily. The drugs were prescribed from the second day of the operation for 5 days.
干预措施: Aspirin (Drug)
Drug: aspirin with ketorolac
The patients received aspirin in a dose of 100 mg and ketorolac 90 mg orally daily. The drugs were prescribed from the second day of the operation for 5 days.
干预措施: Ketorolac (Drug)
Drug: ketorolac and celecoxib
The patients received ketorolac in a dose of 90 mg and celecoxib 400 mg orally daily. The drugs were prescribed from the second day of the operation for 5 days.
干预措施: Ketorolac (Drug)
Drug: ketorolac and celecoxib
The patients received ketorolac in a dose of 90 mg and celecoxib 400 mg orally daily. The drugs were prescribed from the second day of the operation for 5 days.
干预措施: Celecoxib (Drug)
Drug: aspirin, ketorolac and celecoxib
The patients received aspirin in a dose of 200 mg, ketorolac 90 mg, and celecoxib 400 mg orally daily. The drugs were prescribed from the second day of the operation for 5 days.
干预措施: Aspirin (Drug)
Drug: aspirin, ketorolac and celecoxib
The patients received aspirin in a dose of 200 mg, ketorolac 90 mg, and celecoxib 400 mg orally daily. The drugs were prescribed from the second day of the operation for 5 days.
干预措施: Ketorolac (Drug)
Drug: aspirin, ketorolac and celecoxib
The patients received aspirin in a dose of 200 mg, ketorolac 90 mg, and celecoxib 400 mg orally daily. The drugs were prescribed from the second day of the operation for 5 days.
干预措施: Celecoxib (Drug)
结局指标
主要结局
Measuring postoperative pain using the visual analog scale for pain (VAS-P)
时间窗: 5 days
The patients choose the score on the 10 cm line scale with (VAS-P) rage from 0 ('no pain') to 10 (severe pain).
次要结局
- Prothrombin time(5 days)
- Partial thromboplastin time(5 days)
- Hematocrit(5 days)
- Erythrocytes(5 days)
- Fibrinogen(5 days)
- Arachidonic acid-stimulated platelet tests(5 days)
- Platelets cells(5 days)
- Hemoglobin(5 days)