Prolonged Multimodal Analgesia for Post-Discharge Pain Control After Primary Total Hip Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 228
- 试验地点
- 1
- 主要终点
- Pain
研究概览
简要总结
This is a prospective, three-arm, comparative study with a provider-crossover design. The first arm will comprise the standard of care pain regimen after discharge, which comprises PRN oxycodone, tramadol, and acetaminophen. The second arm will comprise a multimodal pain regimen; however, patients will still be routinely provided PRN oxycodone and tramadol to use on an as needed basis. The third arm will comprise a multimodal pain management protocol, which does not routinely allow for opioid consumption. However, patients will be provided a one week supply of oxycodone and tramadol for emergency pain relief only.
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
- Single (Participant)
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
- •Patients undergoing unilateral, primary cementless THA with underlying diagnosis of osteoarthritis.
- •ASA I - III
- •Spinal anesthesia
- •Male and Female over 18 who are willing and able to provide informed consent
排除标准
- •Opioid use within 3 months prior to surgery
- •General anesthesia
- •Non-english speaking
- •ASA IV or greater
- •Allergy/contraindications to protocol medications
- •Renal insufficiency with Cr > 2.0 or hepatic failure
- •Sensory/motor disorder involving the operative limb
- •Planned or unplanned discharge to rehab
- •Length of stay >3 days
- •Revision or conversion THA
- •Cigarette smokers
研究组 & 干预措施
Standard of Care
干预措施: Standard of Care (Drug)
Multi-modal with as needed opioids
干预措施: Multi-modal with as needed opioids (Drug)
Multi-modal with one week of opioids offered
干预措施: Multi-modal with one week of opioids offered (Drug)
结局指标
主要结局
Pain
时间窗: 30 days post-operative
Pain as reported by Visual Analog Scale
total opioid consumption
时间窗: total consumption calcuated from surgery date through 30 days post-op
次要结局
未报告次要终点