2023-506299-28-00招募中4 期
Effect of nonsteroidal anti-inflammatory drugs in the management of postoperative pain after cardiac surgery: A multicentre, randomised, placebo-controlled trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 238
- 试验地点
- 4
- 主要终点
- Postoperative pain at rest will be assessed at 24 hours using a numerical rating scale (NRS) graded from 0 to 10
研究概览
简要总结
Show that the use of NSAIDs reduces pain 24 hours after cardiac surgery
研究设计
- 分配方式
- Randomized
- 主要目的
- Ketoprofen versus placebo in the management of postoperative pain after cardiac surgery
- 盲法
- Double (Subject, Investigator, Analyst, Monitor)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Patient aged 18 or older admitted for elective cardiac surgery under extracorporeal circulation
- •Signed informed consent
排除标准
- •Thoracotomy approach, 2 Minimally invasive approach
- •Renal replacement therapy within the last 90 days
- •Depression with long-term treatment
- •History of gastrointestinal ulcer
- •Chronic use of NSAIDs before the operation
- •Opioid dependence or chronic opioid medication
- •Contraindications to the use of NSAIDs
- •Emergency surgery
- •Acute infectious endocarditis
- •AIDS with a CD4 count <200/mm3
- •Autoimmune disorder
- •Advanced chronic kidney disease (CKD 4 or 5)
结局指标
主要结局
Postoperative pain at rest will be assessed at 24 hours using a numerical rating scale (NRS) graded from 0 to 10
Postoperative pain at rest will be assessed at 24 hours using a numerical rating scale (NRS) graded from 0 to 10
次要结局
- During chest physiotherapy, postoperative pain will be assessed as for the primary endpoint using the NRS
- Postoperative pain every day from the 1st to the 7th day between 8 a.m. and 12 p.m. as for the primary endpoint using the EN and the pain trajectory will be assessed taking into account the NRS between day 3 and day 7
- Nausea will be recorded according to a verbal scale (none, moderate, severe)
- postoperative pulmonary complications will be looked for in the first 7 days after surgery according to the European consensus definitions
- Chronic pain will be assessed at 48 hours and at 3 months by completing a concise pain questionnaire using the DN4 scale
- Neuropathic pain will be assessed at 48 hours
- Quality of life at 3 months will be assessed by the quality of life scale of the EQ-5D-5L questionnaire compared to the assessment the day before surgery
研究者
Coordinating investigator
Scientific
Centre Hospitalier Universitaire Amiens Picardie
研究点 (4)
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