Oral Dexamethasone as an Intervention for Postoperative Pain and Nausea Management in Total Knee Arthroplasty
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 300
- 主要终点
- Postoperative Nausea
研究概览
简要总结
This study aims to determine if oral dexamethasone provides clinically significant improvement in postoperative outcomes, specifically nausea and pain scores.
详细描述
Protocols in perioperative pain management during total joint arthroplasty (TJA) have contributed to early discharge after surgery. As practices move to favor ambulatory surgery in total joint arthroplasty changes must be made to postoperative pain and nausea management. Spinal anesthesia has been essential in managing associated ambulatory TJA, however, nausea and vomiting are known detrimental side effects. The use of systemic steroids has also been shown in the literature to reduce pain scores, length of stay, the need for antiemetics, and increase the distance of ambulation without increasing the rate of surgical site infection or prosthetic joint infection. As more same-day total joint replacement is incorporated into practice, an oral alternative may prove beneficial.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •adult patients age 18 and older who will be undergoing joint replacement
排除标准
- •Patients with uncontrolled diabetes ( HbA1C, >7.5%), impaired hepatic function (Child class, >B), impaired renal failure (Glomerular filtration rate <60 mL/min/1.73 m2), chronic narcotic use, alcohol and/or opioid dependence, patients with a known adverse reaction to corticosteroids, and patients unable to give informed consent.
研究组 & 干预措施
Arm A: Placebo
Participants will be randomly assigned to receive 4 mg placebo taken twice daily for 4 days
干预措施: Placebo (Drug)
Arm B: Oral Dexamethasone
Participants will be randomly assigned to receive 4 mg Oral Dexamethasone taken twice daily for 4 days
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Postoperative Nausea
时间窗: 3 weeks following surgery
Postoperative Nausea will be collected via visual analog scores
Antiemetic Consumption
时间窗: 6 months
Opioid Consumption
时间窗: 6 months
Opioid consumption will be recorded by participant in assigned journal, morphine equivalence will be recorded
Postoperative Pain
时间窗: 3 weeks following surgery
Postoperative pain will be collected via visual analog scores
Episodes of Nausea
时间窗: 3 weeks
次要结局
- Patient-reported outcome scores (PROMS)(6 months)
- Postoperative complications(6 months)
- Knee Injury and Osteoarthritis Outcome Score (KOOS)(6 months)
研究者
Jonathan H. Shaw
Orthopaedic Surgeon
Henry Ford Health System