A Comparative Study on the Efficacy of Periarticular Single Anesthetic Drug Compared With Multimodal Drug Injection in Controlling Pain After Total Knee Arthroplasty: A Double Blinded Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- pain score
研究概览
简要总结
The purpose of this study is to determine the periarticular multimodal drug injection has more efficacy for controlling pain after TKA than single anaesthetic drug injection.
详细描述
Many studies have to determine the efficacy of periarticular multimodal drug injection or single local anaesthetic drug comparing with placebo for pain controlled in TKA. But in this study would like to determine which one of both drugs are more efficacy.
In multimodal drug injection consist of levobupivacaine, morphine, ketorolac and epinephrine while single anaesthetic drug has levobupivacaine and epinephrine.
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 osteoarthritis of the knee who undergoing unilateral primary total knee arthroplasty
- •age 50-85 years old
排除标准
- •unable to perform spinal anaesthesia
- •history of drug allergies; local anaesthesia, Non-steroidal anti-inflammatory drugs, morphine, epinephrine
- •cognitive function impairment
- •renal impairment (creatinine clearance < 30 mL/min)
- •liver impairment, gastrointestinal bleeding
研究组 & 干预措施
multimodal drug injection
Multimodal drug injection Levobupivacaine 150 mg, epinephrine(1:1000) 0.6 mL(0.6 mg), morphine sulfate 5 mL(5 mg), ketorolac 1 mL (30 mg) and mixed with normal saline up to 100 mL
干预措施: multimodal drug injection (Drug)
Single anaesthetic drug
Single anaesthetic drug levobupivacaine 150 mg and epinephrine (1:1000) 0.6 ml (0.6 mg)
干预措施: single anaesthetic drug (Drug)
结局指标
主要结局
pain score
时间窗: 48 hour after surgery
pain score at rest and activity between 2 groups every 4 hours until 48 hours after surgery
次要结局
- time to request analgesic drug(48 hours)
研究者
Supakit Kanitnate
department of orthopeadic surgery
Thammasat University