Efficacy of Pain Management in Different Concentrations of Bupivacaine in Periarticular Injection and Plasma Concentrations of Bupivacaine in Patients Undergoing Bilateral Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- postoperative pain score
研究概览
简要总结
To study efficacy of postoperative pain control of different concentrations of bupivacaine for periarticular infiltration, part of multimodal analgesia, in bilateral total knee arthroplasty.
To study plasma concentration of bupivacaine in patient who received spinal anesthesia and single shot bilateral adductor canal block and periarticular infiltration with bupivacaine for safety level.
详细描述
Adequate postoperative pain control reduce postoperative morbidity, multimodal analgesia techniques is used for achieve this goal. multimodal analgesia for bilateral total knee arthroplasty are peripheral nerve block, periarticular infiltration, NSAIDs, gabapentins and others. patients undergoing bilateral total knee arthroplasty in siriraj hospital receive spinal anesthesia, single shot bilateral adductor canal block and bilateral periarticular infiltration with bupivacaine so patient receive a large dose of bupivacaine. the investigators study the efficacy of postoperative pain of reduced dose of bupivacaine for periarticular infiltration. and study plasma level of bupivacaine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged more than 18 years old
- •American society of anesthesiologists physical status classification 1-3
- •Undergoing bilateral total knee arthroplasty with spinal anesthesia and single shot bilateral adductor canal block
排除标准
- •Allergy to bupivacaine
- •Body weight less than 50 kilograms
- •Hepatic disease
- •Coagulopathy
- •Creatinine clearance less than 60 ml/min
- •Uncontrolled cerebrovascular disease
- •Hematocrit less than 35%
研究组 & 干预措施
bupivacaine 200 mg
bupivacaine 200 mg ketorolac 30 mg epinephrine 400 mcg add NSS to 80 ml divided to two syringes for bilateral periarticular infiltration
干预措施: bupivacaine 200 mg (Procedure)
bupivacaine 100 mg
bupivacaine 100 mg ketorolac 30 mg epinephrine 400 mcg add Normal saline solution(NSS) to 80 ml divided to two syringes for bilateral periarticular infiltration
干预措施: bupivacaine 100 mg (Drug)
结局指标
主要结局
postoperative pain score
时间窗: 0-24 hours postoperative
Numerical rating scale at rest and movement in the first 24 hours postoperatively
次要结局
- plasma bupivacaine level(40 minutes after 1st articular infiltration, 15,30,45,60,90 minutes after 2nd periarticular infiltratio)
- ambulation(48 hours postoperatively)
- postoperative morphine consumption(first 24 hours and 24-48 hours postoperatively)