Effectiveness of Intraoperative Exparel, a Bupivacaine Liposome Injectable Suspension, for Postoperative Pain Control in Total Knee Arthroplasty: A Prospective, Randomized, Double Blind, Controlled Study
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 100
- 主要终点
- Postoperative opioid consumption
研究概览
简要总结
Does the use of periarticular Exparel in total knee arthroplasty prove to more effectively manage post operative pain control than another local analgesic, Ropivacaine, when both are used as part of a multimodal pain management approach?
The investigators hypothesize that Exparel, a bupivacaine liposomal injectable suspension, will improve total knee arthroplasty postoperative pain with significant improvement of early function outcomes.
详细描述
The investigators use a double blind, controlled, randomized study to examine the effectiveness of periarticular Exparel in total knee arthroplasty postoperative pain control as well as effect on early mobilization and length of hospital stay when compared to another local analgesic (Ropivacaine) when both are used as part of a multimodal pain management approach.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient undergoing Total Knee Arthroplasty with Dr. J.H. DeClaire
- •18 years of age or older
- •Primary diagnosis of osteoarthritis of the knee
- •Opioid naïve patient (according to FDA guidelines)
排除标准
- •Prior knee replacement
- •Prior use of narcotics for chronic pain management
- •Inflammatory arthritis (Rheumatoid arthritis, Lupus, etc.)
- •Unicompartmental knee replacement
- •Bilateral Total Knee Arthroplasty
- •Opioid Tolerant as defined by the FDA: Patients who are taking, for one week or longer, at least:
- •> 60 mg oral morphine/day > 25μg transdermal fentanyl/hour > 30 mg oral oxycodone/day > 8 mg oral hydromorphone/day > 25 mg oral oxymorphone/day
研究组 & 干预措施
Pain Cocktail with Ropivacaine
patients given the standard intra-articular "pain cocktail" injection, consisting of ropivacaine, ketorolac, morphine, and epinephrine mixed with saline into a 100cc preparation.
given in one single dose
干预措施: Pain Cocktail with Ropivacaine (Drug)
Pain Cocktail with Exparel
patients given a similar intra-articular injection consisting of bupivacaine, ketorolac, morphine, and epinephrine mixed with saline into a 80cc preparation as well as an injection of Exparel, 20cc of 1.3% Exparel, to total 100cc.
given in one single dose
干预措施: Pain Cocktail with Exparel (Drug)
结局指标
主要结局
Postoperative opioid consumption
时间窗: immediately post-operatively through hospital stay
oral and intravenous narcotic consumption is recorded during hospital stay
次要结局
- Hours to ambulate 100 feet(immediately post-operatively through hospital stay)
- Length of hospital stay (hours)(immediately post-operatively through hospital stay)
- Visual Analog Pain Score(day 1 and day 2 after operation, 3 months, 6 months, and 1 year operatively)
- Knee Society Score(3 months, 6 months, 1 year postoperatively)