Analgesic Efficacy of Liposomal Bupivacaine in Total Knee Arthroplasty
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Mean visual analog scale (VAS) pain scores
研究概览
简要总结
Liposomal bupivacaine is a novel local anesthetic designed for prolonged pain relief. Despite its long-acting analgesic potential, liposomal bupivacaine is significantly more expensive than other local anesthetic alternatives. The primary aim of this investigation is to examine whether or not liposomal bupivacaine provides superior pain relief or clinically significant opioid-sparing effects versus a control to justify its cost.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing a primary unilateral total knee arthroplasty by the PI of the trial
排除标准
- •Patients with a sensitivity to marcaine
- •Pregnant or lactating women
- •Non-English speaking individuals
研究组 & 干预措施
Liposomal bupivacaine
Periarticular infiltration of 20cc of liposomal bupivacaine with 20cc of normal saline administered prior to cementation of knee implants
干预措施: Liposomal bupivacaine (Drug)
bupivacaine HCl, morphine, epinephrine, methylprednisolone
Periarticular infiltration of 24c of bupivacaine HCl, 0.8cc morphine, 0.3cc epinephrine, and 1cc of methylprednisolone administered prior to cementation of knee implants
干预措施: bupivacaine HCl, morphine, epinephrine, methylprednisolone (Drug)
结局指标
主要结局
Mean visual analog scale (VAS) pain scores
时间窗: Post-operative day 2
Self-reported pain scores from 0=no pain to 10=severe pain
Pain assessment phone call
时间窗: Post-operative day 3
Subjects will be called on post-operative day three by one of the investigators of the study. Subjects will be asked to rate their current pain level from 1 to 10 and to rate their worst pain level from 1 to 10 that day.
次要结局
- Complications(Complications will be followed for the duration of patients' hospital stay, an expected average of 2-3 days.)