NCT02060591Unknown不适用
Comparison of Two Periarticular Injection Medications for Adjunctive Pain Management Following Total Knee Arthroplasty (TKA)
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 试验地点
- 1
- 主要终点
- 2. Measure pain intensity score (pre and post-operatively) by visual analogue scale (VAS) method
研究概览
简要总结
The Investigators aim to study the efficacy of Exparel as compared to Marcaine, taking into account pain control, narcotic consumption, narcotic-related side effects, outcomes measures, and patient satisfaction. Moreover, the Investigators plan to perform cost-benefit analysis to evaluate whether use of Exparel decreases analgesic consumption, duration of hospital stay and the need for physical therapy postoperatively, therefore, offsetting its higher price in comparison with Marcaine.
研究设计
- 研究类型
- Interventional
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
- •All patients at least 18 years old who have primary unilateral TKA for osteoarthritis performed at Thomas Jefferson University Hospital.
排除标准
- •American Society of Anesthesiologist (ASA) score of 4 or higher
- •Hepatic disease (contraindication for acetaminophen)
- •Renal disease (contraindication for NSAIDs)
- •Any contraindication for oxycodone, ketorolac, epinephrine, pregabalin, gabapentin, hydromorphone, Tramadol, morphine or other narcotics that are considered as part of routine postoperative pain control protocol
- •Fibromyalgia
- •Any contraindication for intrathecal opioid injection
- •History of substance abuse during the last 2 years
- •History of allergy to amide compounds
- •Current consumption of monoaminoxidase (MAO) inhibitors and tricyclic antidepressant (TCA) medications
- •Allergy to metabisulfite compounds
- •Chronic use of opioid medications in the month prior to surgery (leads to opioid tolerance and/or opioid-induced hyperalgesia)
- •Body weight<50 Kg, BMI>40 Kg/m2
- •History of hypotension
- •Patients with any surgery related complication in the first 4-6 weeks following TKA, such as infection or mechanical failure
研究组 & 干预措施
Exparel
Active Comparator
干预措施: Exparel (Drug)
Marcaine
Active Comparator
干预措施: Marcaine (Drug)
结局指标
主要结局
2. Measure pain intensity score (pre and post-operatively) by visual analogue scale (VAS) method
时间窗: Within first 30 days post-operatively
次要结局
未报告次要终点
研究者
研究点 (1)
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