NCT01187537已完成不适用
Effects of Continuous Femoral Nerve Block Versus Single-Injection Femoral Nerve Block With Intravenous Patient Controlled Analgesia Versus Intravenous Patient Controlled Analgesia on Knee Pain and Function After Total Knee Replacement
Tan Tock Seng Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2009年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Incidence of patients with significant pain on movement on day 1 post surgery
研究概览
简要总结
The purpose of this study is to compare the effectiveness of three analgesia techniques on pain relief and functional recovery after knee replacement: continuous femoral nerve block vs single-injection femoral nerve block with intravenous patient controlled analgesia vs intravenous patient controlled analgesia.
详细描述
Primary Outcome Measures:
- Incidence of patients with significant pain on movement on day 1 post surgery
- Range of knee flexion
Secondary Outcome Measures:
- Pain intensity (rest/movement)
- Functional recovery
- Knee Injury and Osteoarthritis Score
- Side effects/ Adverse outcomes
- SF12 Quality of Life Questionnaire
- Length of stay
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •40 years and above
- •Osteoarthritis
- •Primary unilateral total knee replacement
- •No other lower extremity joint disease
- •ASA I-III
- •Body mass index < 35
- •No severe cardiac or pulmonary diseases
- •No chronic narcotic therapy or illicit drug use
- •Mentally competent to understand study procedures and use of pain scales
- •Able to provide informed consent
排除标准
- •Any cause for knee replacement other than osteoarthritis
- •Total knee revision
- •Any contraindication for femoral block
- •Abnormal coagulation studies
- •Thrombocytopenia less than 100,000/cc
- •Known hepatic or renal insufficiency
- •Neurological disease involving lower extremities
- •Major surgery during the last 2 weeks pre-operatively
- •History of allergy to study medications
- •History of post-operative bleeding over 2000 cc/24 hours
- •History of opioid or alcohol abuse
- •Currently taking or has taken opioid > 30 consecutive days of daily use at a daily dose > 15mg morphine, within the past 2 weeks prior to surgery
- •Previously has not responded to opioid analgesics for treatment of pain
- •Pregnancy or breastfeeding
结局指标
主要结局
Incidence of patients with significant pain on movement on day 1 post surgery
时间窗: Post op day 1
次要结局
- Functional recovery(During hospitalization, week 2, week 12)
研究者
Chan Ee Yuee
Dr
Tan Tock Seng Hospital
研究点 (1)
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