Effect of Adductor-Canal-Blockade on High Pain Responders the 1. or 2. Postoperative Day After Total Knee Arthroplasty
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Difference in VAS between ACB and placebo during active 45 degrees knee flexion
研究概览
简要总结
The purpose of this study is to determine whether Adductor-Canal-Blockade (ACB) is superior to placebo when it comes to analgetic efficacy in high pain responders after Total Knee Arthroplasty (TKA). High pain responders are defined as patients reporting VAS > 60 during knee flexion the 1. or 2. day after surgery.
详细描述
The patients will be included the 1. or 2. day after surgery. All TKA patients will be screened. Those reporting VAS > 60 during active 45 degrees knee flexion will be asked to participate.
Included patients will receive 2xACB (singleshot) first placebo (30ml saline) and then ropivacaine (30ml 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
- •TKA within 48 hours and VAS>60 during active 45 degrees knee flexion despite conventional pain medication.
- •Informed consent
- •BMI 18-40
排除标准
- •Unable to communicate in Danish
- •Allergic reactions toward drugs used in the
- •Abuse of alcohol/drugs
- •Unable to cooperate
研究组 & 干预措施
Arm RP
first blockade: ropivacaine 7,5mg/ml 30 ml second blockade: placebo: saline 30 ml
干预措施: Ropivacaine (Drug)
Arm RP
first blockade: ropivacaine 7,5mg/ml 30 ml second blockade: placebo: saline 30 ml
干预措施: Saline (Drug)
Arm PR
first blockade: placebo: saline 30 ml second blockade: ropivacaine 7,5mg/ml 30 ml
干预措施: Ropivacaine (Drug)
Arm PR
first blockade: placebo: saline 30 ml second blockade: ropivacaine 7,5mg/ml 30 ml
干预措施: Saline (Drug)
结局指标
主要结局
Difference in VAS between ACB and placebo during active 45 degrees knee flexion
时间窗: 45 minutes
次要结局
- Difference in mean VAS between the groups at rest(15, 30, 60, 75 and 90 minutes)
- Difference in mean VAS between the groups during active knee flexion(15, 30, 60, 75 and 90 minutes)
研究者
Ulrik Grevstad
Consultant
University Hospital, Gentofte, Copenhagen