Effect of the Serratus Plane Block on the Outcome in Patient With Multiple Rib Fractures: A Prospective, Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Pulmonary change function
研究概览
简要总结
Patients with ipsilateral multiple rib fractures will be randomized to receive either a single-shot ultrasound-guided serratus plane block, or a continuous serratus plane block within 24h from the chest trauma. Primary outcome is the difference in forced respiratory volume (FEV1) at 72h.
详细描述
Patients admitted in emergency department with a chest trauma and ipsilateral multiple rib fractures, will be randomized as described above. All patients will receive the serratus block with a ropivacaine 0.37% solution 20 ml. Then, they will randomized to receive either a peripheral catheter placed above the 5th rib on the middle axillary line, or nothing. In all patients postoperative analgesia also include Paracetamol 1g IV each 6h and a patient controlled analgesia (PCA) of morphine set out as follow: bolus 1 mg, loch out 15 min, max 4 boluses each hour. In all patients an arterial blood sample for gas analysis and a FEV1 will be achieved before the block, after 1 hour and at 72h.
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
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •2 o more ipsilateral rib fractures
- •Trauma within 24h from hospital admission
- •Informed consent
排除标准
- •Chest drain
- •head trauma
- •bilateral rib fractures
- •Intensive care admission
结局指标
主要结局
Pulmonary change function
时间窗: day 0 and day 3
FEV 1
次要结局
- Morphine(day 0, day 1, day 2, day 3, day 4)
- Numerical rating scale (NRS) of pain(day 0, day 1, day 2, day 3, day 4)
- hospital stay(day 1, day 2, day 3, day 4, day 5, day 6, day7)