Effect of Nervus Cutaneous Femoris Lateralis-Blockade on Moderate Pain Responders After Total Hip Arthroplasty
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Difference in VAS between NCFL and placebo during active 30 degrees hip flexion
研究概览
简要总结
The patients will be included the 1. or 2. day after surgery. All THA patients will be screened. Those reporting VAS > 40 during active 30 degrees hip flexion will be asked to participate.
Included patients will receive 2xNCFL (singleshot) first placebo (8 ml saline) and then ropivacaine (8 ml ropivacaine 7,5mg/ml) or the other way around (randomized). There will be 45 minutes between the two blockades. The blockades will be ultrasound guided.
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
- 30 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •THA within 48 hours and VAS>40 during active 30 degrees hip flexion despite conventional pain medication.
- •informed consent
- •BMI 18-40
排除标准
- •Unable to communicate in danish
- •Allergic reactions toward drugs used
- •Abuse of alcohol/drugs
- •Unable to cooperate
- •Pregnant women
研究组 & 干预措施
RP
first blockade: ropivacaine 7,5mg/ml 8 ml second blockade: placebo: saline 8 ml
干预措施: Ropivacaine (Drug)
RP
first blockade: ropivacaine 7,5mg/ml 8 ml second blockade: placebo: saline 8 ml
干预措施: Saline (Drug)
PR
first blockade: placebo: saline 8 ml second blockade: ropivacaine 7,5mg/ml 8 ml
干预措施: Ropivacaine (Drug)
PR
first blockade: placebo: saline 8 ml second blockade: ropivacaine 7,5mg/ml 8 ml
干预措施: Saline (Drug)
结局指标
主要结局
Difference in VAS between NCFL and placebo during active 30 degrees hip flexion
时间窗: 45 min
次要结局
- Difference in mean VAS between the groups during active hip flexion(15, 30, 45, 60, 75, 90 min)
- Difference in mean VAS between the groups at rest(15, 30, 45, 60, 75, 90 min)
研究者
Daniel Hägi-Pedersen
Consultant
Naestved Hospital