Multi-Modal Pain Management After Outpatient Orthopaedic Surgery: A Prospective Randomized Trial
试验速览
- 阶段
- 3 期
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Postoperative Pain
研究概览
简要总结
Following outpatient orthopaedic surgery, adequate pain control is imperative both for patient satisfaction and for improved recovery and rehabilitation. Opioids are frequently utilized for postoperative pain control, however they can be addictive and are known to have many deleterious effects. Recent studies have demonstrated the effectiveness of a wide variety of multi-modal postoperative pain regimens in providing adequate pain control while also decreasing opioid usage. However, the most effective multi-modal pain regimen for postoperative pain control remains unclear. This prospective, randomized study intends to investigate the efficacy of a multi-modal postoperative pain regimen compared to a traditional opioid-only pain regimen following elective outpatient orthopaedic surgery of the hand, wrist, foot, or ankle.
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
- None
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
- •Age ≥ 18 years old
- •undergoing elective outpatient orthopaedic surgery under general anesthesia.
排除标准
- •Age < 18 years old
- •Non-English speaking
- •allergy to or medical contraindication to taking oxycodone (or other opioids), acetaminophen, or Naprosyn (or other NSAIDs).
- •currently taking opioid medications
- •history of chronic opioid therapy for chronic pain
- •surgery being performed under local anesthesia only, without general anesthesia or sedation
研究组 & 干预措施
Oxycodone Group (Control Group)
Patients will receive oxycodone as needed after surgery
干预措施: OxyCODONE 5 mg Oral Tablet (Drug)
Oxycodone+ Naproxen/Acetaminophen (Study Group)
each patient will receive oxycodone plus acetaminophen and naproxen for 2 weeks after surgery
干预措施: OxyCODONE 5 mg Oral Tablet (Drug)
Oxycodone+ Naproxen/Acetaminophen (Study Group)
each patient will receive oxycodone plus acetaminophen and naproxen for 2 weeks after surgery
干预措施: Acetaminophen 500Mg Tab (Drug)
Oxycodone+ Naproxen/Acetaminophen (Study Group)
each patient will receive oxycodone plus acetaminophen and naproxen for 2 weeks after surgery
干预措施: Naproxen 500 Mg (Drug)
结局指标
主要结局
Postoperative Pain
时间窗: 14 days
With the use of an 11 point numeric rating scale (NRS) daily satisfaction with their pain regimen, patients pain level and medication usage will be recorded.
次要结局
未报告次要终点