Multimodal Opiate-sparing Analgesia Versus Traditional Opiate Based Analgesia After Cardiac Surgery, a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Evaluation of analgesic effect by 11-NRS scale
研究概览
简要总结
To test if multimodal analgesia with different analgesic medication offer better pain relief, lesser side effects and is safe compared to conventionel opiod analgesia after cardiac surgery.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •any cardiac procedure with sternotomy
- •able to give informed consent
排除标准
- •cardiac surgery without sternotomy
- •peripheral neuropathy
- •neurological disease
- •psychiatric illness
- •history of GI bleeding
- •chronic pain (i.e. back pain, cancer, arthritis)
- •serum creatinine >150 μmol/l
- •hepatic disease with elevated liver enzymes (SGPT and SGOT elevated to 1.5 times maximum normal value)
- •allergic to study medication
- •alcohol abuse
- •abuse of narcotics or medication
- •pregnancy
- •participation in other clinical trials
- •insufficient language skills
- •In addition intensive care unit (ICU) stay for more than 24 hours was used as a pre-defined post randomization exclusion criteria, because prolonged ICU stay and ventilator treatment would interfere with study analgesic protocol.
研究组 & 干预措施
Multimodal
oral Ibuprofen 400mg 4 times daily oral Gabapentin 300mg twice daily oral Paracetamol 1000mg 4 times daily
干预措施: Ibuprofen (Drug)
Multimodal
oral Ibuprofen 400mg 4 times daily oral Gabapentin 300mg twice daily oral Paracetamol 1000mg 4 times daily
干预措施: Gabapentin (Drug)
Multimodal
oral Ibuprofen 400mg 4 times daily oral Gabapentin 300mg twice daily oral Paracetamol 1000mg 4 times daily
干预措施: Paracetamol (Drug)
Morphine
oral Morphine 10mg 4 times daily oral paracetamol 1000mg 4 times daily
干预措施: Morphine (Drug)
Morphine
oral Morphine 10mg 4 times daily oral paracetamol 1000mg 4 times daily
干预措施: Paracetamol (Drug)
结局指标
主要结局
Evaluation of analgesic effect by 11-NRS scale
时间窗: 4th postoperative day
assessement of analgesic effect for the first 4 days after surgery
次要结局
- Hospital stay in days.(days until discharge)
- Evaluation of side-effects by daily questionnaire(4th postoperative day)
- Additional analgesic consumption(4th postoperative day)
- Cardiac complications(30th postoperative day)
- 30 day Mortality(30th postoperative day)
- Other complications(30th postoperative day)
研究者
Sulman Rafiq
MD
Rigshospitalet, Denmark