NCT01593319终止4 期
Is Regional Anesthesia of the Hip Preferable Over Traditional Analgesia in the Acute Stage of the Management of Patients With a Fracture of the Hip
Landstinget i Värmland1 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2012年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Pain
研究概览
简要总结
The main hypothesis of the study is that anaesthesia of the hip using infiltration with a local anesthetic solution is preferable over traditional analgesia with oral opioid medications in the acute stage of the management of patients with a fracture of the hip.
To study the hypothesis the investigators designed a prospective randomised study where patients are assigned in two groups, the first receiving local hip anesthesia and the other placebo treatment. Both groups are eligible to use of standard oral pain treatment.
Effect of analgesia as well as medical complications will be recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •fracture of the hip
排除标准
- •multiple fractures,
- •delay (more than 12 hours) from the time of injury until admission to the hospital,
- •local infections, hypersensitivity to local analgetics,
- •cognitive impairment
研究组 & 干预措施
ropivacaine
Active Comparator
干预措施: Ropivacaine (Drug)
Natrium chloride
Placebo Comparator
干预措施: Natrium chloride (Drug)
结局指标
主要结局
Pain
时间窗: 3 hours
次要结局
- medical complications (Number of participants that develop pressure ulcers, number of participants that develop pneumonia)(under hospitalization (expected average of 10 days))
研究者
Panagiotis Tsagkozis
MD, PhD
Landstinget i Värmland
研究点 (1)
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