Effect of Local Infiltration Analgesia With Ropivacaine in Total Hip Arthroplasty: a Prospective, Randomized, Double-blind, Placebo-controlled Trail
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Postoperative pain scores on the Visual Analog Scale (during walking)
研究概览
简要总结
The purpose of the study is to compare the effects of per-operative local infiltration analgesia with ropivacaine 0,2 % (150 ML) versus placebo on acute postoperative pain intensity after total hip arthroplasty.
The hypothesis is that local infiltration analgesia reduces the acute postoperative pain intensity.
详细描述
In spite of being one of the last century's most successful surgical procedures in treatment of advanced osteoarthritis total hip arthroplasty is still associated with postoperative pain and delayed rehabilitation. We therefore decided to evaluate the effects of per-operative local infiltration analgesia with ropivacaine 0,2 % (150 ML) versus placebo on acute postoperative pain intensity in a well defined, multimodal, fast-track setup after hip arthroplasty. The technique is widely used as standard treatment in many European centers despite its limited evidence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective total hip arthroplasty
- •Able to speak and understand danish
- •Able to give informed consent
排除标准
- •Alcohol or medical abuse
- •Allergies to local anesthetics
- •Age < 18 years
- •Daily use of opioids or glucocorticoids
- •Pregnancy or breastfeeding
- •Opioid intolerance
- •Obesity defined as BMI>40 kg/m2
- •Diabetic neuropathy and rheumatoid arthritis
研究组 & 干预措施
Local infiltration with ropivacaine
Local infiltration with ropivacaine 0,2% (150 ML)
干预措施: Ropivacaine (Drug)
Local infiltration with saline
Local infiltration with saline (150 ML) (placebo)
干预措施: Ropivacaine (Drug)
结局指标
主要结局
Postoperative pain scores on the Visual Analog Scale (during walking)
时间窗: up to 8 hours
次要结局
- Additional analgetics measured as cumulated amount i mg(up to 8 hours)
- Time spend in hospital measured as nights after surgery(At discharge (mean 2-3 nights))
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability(up to 8 hours)
- Postoperative pain scores on the Visual Analog Scale (at rest)(up to 8 hour)
研究者
Troels Haxholdt Lunn
MD
Hvidovre University Hospital