Postoperative Pain in Total Knee Arthroplasty: a Comparison Between General and Spinal Anesthesia
试验速览
- 阶段
- 4 期
- 入组人数
- 60
- 主要终点
- postoperative pain measured by Visual Analogue Scale
研究概览
简要总结
Total knee arthroplasty may be conducted either under general anesthesia or spinal block. previous studies have shown that spinal block leads to less complications. The investigators aim to find whether post-operative pain is also diminished under spinal block compared to general anesthesia
详细描述
Patients who will be registered for a total knee replacement in Meir Medical Center and that will agree to participate in the study will be enrolled into one of two groups: the first, which will be the default choice for all patients, will be operated under a spinal block. Patients who will ask specifically for general anesthesia, or those in which the anesthesiologist will prefer general anesthesia due to medical reasons will be enrolled into the second group. For both groups the surgeon will add intraoperative peri-articular infiltration of local Marcaine injections, which was previously shown to diminish postoperative pain. The postoperative pain will be evaluated with the Visual Analogue Scale at different point during the first 48 hours following operation. Physiotherapy achievements will also be recorded. The investigators will try to find whether one of the two groups suffered less pain or had achieved better results in physical therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all patient who will undergo total knee arthroplasty
排除标准
- •patients who will not agree to participate in the study
- •patients who will die during the research timeframe
研究组 & 干预措施
Spinal block
Intrathecal 10 mg Heavy Marcaine, 200 mcg Morphine + High volume local anesthesia infiltration Bupivacaine 5mg/ml + adrenaline 5 mcg/ml 3mg/kg ideal body weight diluted with 100cc Normal Saline
- Total Knee Replacement ( which will not be the intervention of interest)
干预措施: Spinal Block (Drug)
Spinal block
Intrathecal 10 mg Heavy Marcaine, 200 mcg Morphine + High volume local anesthesia infiltration Bupivacaine 5mg/ml + adrenaline 5 mcg/ml 3mg/kg ideal body weight diluted with 100cc Normal Saline
- Total Knee Replacement ( which will not be the intervention of interest)
干预措施: Total knee replacement (Device)
General anesthesia
1-3 mg IV propofol 0.5 mg/kg IV Rocuronium + Fentanyl 2-3 mcg/kg + Morphine 0.1mg/kg IV Maintenance: Volatile anesthetic + High volume local anesthesia infiltration Bupivacaine 5mg/ml + adrenaline 5 mcg/ml 3mg/kg ideal body weight diluted with 100cc Normal Saline
- Total Knee Replacement ( which will not be the intervention of interest)
干预措施: General anesthetic (Drug)
General anesthesia
1-3 mg IV propofol 0.5 mg/kg IV Rocuronium + Fentanyl 2-3 mcg/kg + Morphine 0.1mg/kg IV Maintenance: Volatile anesthetic + High volume local anesthesia infiltration Bupivacaine 5mg/ml + adrenaline 5 mcg/ml 3mg/kg ideal body weight diluted with 100cc Normal Saline
- Total Knee Replacement ( which will not be the intervention of interest)
干预措施: Total knee replacement (Device)
结局指标
主要结局
postoperative pain measured by Visual Analogue Scale
时间窗: 48 hours
Visual Analogue Scale scores of pain will be documented at different timed during the first 48 postoperative hours
次要结局
- Achievements in physical therapy measured by walking distance on the first postoperative day(24 hours)
研究者
David segal
Principle Investigator
Meir Medical Center