NCT01119209已完成4 期
Postoperative Analgesia With Local Infiltration After Hip Fracture Of Intertrochanteric Type
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Consumption of opioids
研究概览
简要总结
Reducing pain is an essential factor for early mobilization after osteosynthesis of intertrochanteric fractures. Systemic opioids have side effects that might obstruct mobilization and induce delirium and nausea. The investigators hypothesized that wound infiltration results in reduction in systemic opioid usage and pain relief without side effects.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Intertrochanteric hip fracture
- •Fracture due to low energy trauma
- •Ability to understand danish and give informed consent
- •Ability to walk before trauma
- •Indication for osteosynthesis
- •≥ 8 in OMC (Orientation-Memory-Concentration) test with a possible maximum of 28 points
- •Informed consent
排除标准
- •Drug or medical abuse
- •Drug intolerance
- •Pathological fractures
- •Inflammatory arthritis
- •Patient included in the study with the contralateral hip
研究组 & 干预措施
Ropivacaine
Active Comparator
干预措施: Ropivacaine (Drug)
Ropivacaine
Active Comparator
干预措施: Saline (Drug)
Saline
Placebo Comparator
干预措施: Saline (Drug)
结局指标
主要结局
Consumption of opioids
时间窗: 5 days postoperatively
次要结局
- Pain(5 days postoperatively)
研究者
研究点 (1)
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