Gonyautoxins Local Periarticular Injection for Pain Management After Total Knee Arthroplasty: A Double Blind Randomized Study
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- morphine consume
研究概览
简要总结
The aim of this study is to demostrate the eficcacy in pain control management after total knee arthroplasty of Gonyautoxin. Local administration during surgery of Gonyautoxin before wound closure can achieved better pain control and lower morphin use during hospital stay compared to local administration of chirocaine, ketorolac 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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who required total knee arthroplasty due to knee osteoarthritis ( Kellgren and Lawrence score of 2 or more), with no response to conservative management.
- •Without known allergies to the drugs used in the study
- •Anesthetic risk: ASA Score 1,2,3.
排除标准
- •Obesity, defined as body Mass index over 35
- •Previous Knee surgery
- •Mellitus diabetes
- •Organic brain damage
- •Rheumatic Arthritis
- •Coagulation deficit
- •Liver disease
- •Chronic obstructive pulmonary disease
- •Chronic consumption of opiods
- •Refusal to participate in the study
研究组 & 干预措施
Gonyautoxin
Gonyautoxin 40mcg
干预措施: Gonyautoxins (Drug)
Control
Mix of chirocaine 0,2%, ketorolac and epinephrine..
干预措施: Chirocaine ketorolac epinephrine (Drug)
结局指标
主要结局
morphine consume
时间窗: 60hrs post surgery
total consumption of morphine at 60 hours after total knee arthroplaty
range of motion 1
时间窗: 12hours post surgery
Range of motion of the knee that underwent arthroplasty after 12 hours of surgery
次要结局
- range of motion 2(36 hours after surgery)
- time of up and go test 2(2 days after surgery)
- pain visual analague scale 1(12 hours post surgery)
- pain visual analague scale 2(36 hours post surgery)
- early morphine consume(1 day after surgery)
- range of motion 3(60 hours after surgery)
- pain visual analague scale 3(60 hours post surgery)
- time of up and go test 1(1 day after surgery)
研究者
maximiliano barahona vasquez
MD, MBiostat
University of Chile