Effect of the Injection of Local Analgesia With Epinephrine During Total Hip Arthroplasty on the Blood Losses Per and Operatively.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- measuring volume of cumulated bleeding per and post operative and analyse of complete blood count (CBC)
研究概览
简要总结
The aim is to determine if the use of infiltration with an adrenalin solution in the operative field of Total Hip Arthroplasty (THA), allays a significant reduction of the cumulated volume of bleeding (pre and post operative) without increasing the per and post operative risks. At the same time, the effect on the post operational pains is evaluated.
详细描述
This prospective randomized study compares a population receiving a local anaesthetic (ropivacaine, adrenalin and physiological serum) in the operative field to a population undergoing a standard protocol.
The cumulated volume of bleeding per and post operative are recorded and complete blood count (CBC).
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 (Participant)
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary total hip arthroplasty
- •Age between 50 and 85
排除标准
- •fracture of the femoral neck
- •patients with contraindications for local anaesthesia
研究组 & 干预措施
Ropivacaine, serum, adrenalin
235 mg of ropivacaine, 5 ml physical serum and 0.5 mg of adrenalin.
干预措施: ropivacaine, physical serum and adrenalin (Drug)
结局指标
主要结局
measuring volume of cumulated bleeding per and post operative and analyse of complete blood count (CBC)
时间窗: pre and post operative
次要结局
- Womac score pre operative, at 3 months and at 12 months(at 3 months and 12 months)
- Visual analogue pain score (VAS) during hospitalisation(at 3 months and 12 months)
- Consumption of analgesics(at 3 months and 12 months)