Analgesic Effect of Perioperative Gabapentin in Total Knee Arthroplasty: A Randomized, Double-blind, Placebo-controlled, Dose-response Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 3
- 主要终点
- Pain
研究概览
简要总结
Pain is a major problem after TKA. Gabapentin may reduce acute postoperative pain. The investigators therefore investigate the effect of Gabapentin as a perioperative analgesic.
详细描述
Pain is a major problem after TKA. Studies indicate that Gabapentin may reduce acute postoperative pain. However, the optimal dose is unknown and there is constant controversy on analgesic versus side-effects. The investigators therefore investigate the effect of Gabapentin as a perioperative analgesic in a dose-related manner and with a sample-size allowing evaluation of 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
- 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, unilateral total knee arthroplasty (TKA)
- •Age 50-85 years
- •Ethnic Danes
排除标准
- •Treatment with gabapentins, systemic glucocorticoids, opioids, anxiolytic agents, antiepileptics or antidepressive agents (last 4 weeks)
- •History of depression or mania
- •History of alcohol or drug abuse
- •History of malignancy
- •History of epilepsia
- •BMI > 40
- •Disease affecting central or peripheral nerve function
- •History of dementia
- •History of renal insufficiency
- •Allergy to Gabapentin
- •Women with menstruation (last 2 years)
研究组 & 干预措施
Placebo
Placebo tablets for 7 days, starting on the day of surgery
干预措施: Placebo (Drug)
Gabapentin "high"
Tables with Gabapentin (1300 mg/day) for 7 days, starting on the day of surgery
干预措施: Gabapentin (Drug)
Gabapentin "intermediate"
Tables with Gabapentin for 7 days (900 mg/day), starting on the day of surgery
干预措施: Gabapentin (Drug)
结局指标
主要结局
Pain
时间窗: At 24 hour
Pain during walking at 24 hour after surgery, visuel analog scale (VAS, 0-100 mm)
次要结局
- Amount of ondansetron and sleeping medicine(1 week)
- Anxiety and depression(1 week)
- Gabapentin level in blood-sample(1 Day)
- Sedation(At 6 hours)
- Pain(1 week)
- Cumulated pain scores(1 week)
- Amount of rescue analgesic(1 week)
- Side effects(1 week)
- Cumulated side effects scores(1 week)
研究者
Troels Haxholdt Lunn
MD, principal and koordinating investigator
Hvidovre University Hospital