Gabapentin for Postoperative Pain Management After Cardiac Surgery With Median Sternotomy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Morphine consumption
研究概览
简要总结
In this study we will focus on the postoperative recovery. A successful postoperative recovery should bring the patient to at least to the pre-surgical level. This can probably be achieved by a multimodal approach where at least postoperative pain and PONV are managed.
The surgical injury results in immobilisation which again can result in impaired cardiac, respiratory and musculoskeletal system. Pain relief is a prerequisite for mobilisation and an early return to the pre-surgical level. The preferred drugs for postoperative pain management are opioids. Although opioids are known to be an effective analgesia, they have a series of side effects: nausea, vomiting, constipation, respiratory deficiency, delirium among others.
Gabapentin has been tested for post operative pain. Randomized Clinical Trials have reported a significant better pain scores with Gabapentin in several studies -most of them restricted to the postoperative period in the post-anaesthesia care unit in many different kind of surgeries.
We want to test if Gabapentin can be used instead of opioids for treatment of postoperative pain after heart surgery by median sternotomy.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for elective cardiac surgery with median sternotomy at the department of cardiac surgery, Aarhus University Hospital, Skejby.
- •Patients older than 18 years.
排除标准
- •Patients unable to cooperate.
- •Known allergy for Gabapentin or opioids.
- •Acute pancreatitis
- •History of gastric or peptic ulcer.
- •History of alcohol or drug abuse.
- •Chronic pain or daily intake of analgesics or corticosteroids.
- •Gastrointestinal obstruction
- •Impaired liver function.
- •Impaired kidney function.
- •Previous operation with median sternotomy
- •Pregnant women
研究组 & 干预措施
1
Gabapentin group
干预措施: Gabapentin group (Drug)
结局指标
主要结局
Morphine consumption
时间窗: 1 month
Pain
时间窗: 1 month
次要结局
- PONV(1 month)
- Medication side effects(1 month)
- Hospital stay(1 month)
- VAS score and medication 30 days after the operation(1 month)