A Randomized, Placebo-Controlled Study to Evaluate the Efficacy of Perioperative Dextromethorphan Compared to Placebo for the Treatment of Postoperative Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Post-op opioid use
研究概览
简要总结
A Randomized, Placebo-Controlled Study to Evaluate the Efficacy of Perioperative Dextromethorphan compared to Placebo for the Treatment of Postoperative Pain
详细描述
There is extensive preclinical evidence that dextromethorphan has an analgesic effect in patients with pain of traumatic origin. The primary objective is to of this study is to evaluate the efficacy of perioperative dextromethorphan compared to placebo for postoperative pain in patients undergoing total knee arthroplasty (TKA).
This is a single-institution, multi-dose, randomized, placebo-controlled, trial to evaluate the efficacy of perioperative dextromethorphan compared to placebo for postoperative pain in patients undergoing TKA. Male and/or female patients will be randomized to either dextromethorphan treatment group (n = 80) or placebo group (n= 80).
Patients will receive 60 mg oral dextromethorphan (or matching placebo) preoperatively, as well as 30 mg 8- and 16-hours postoperatively.
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
- Triple (Participant, Care Provider, 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
- 否
入选标准
- •Patients Age ≥18 planning to undergo total knee arthroplasty
- •ASA classes I - III
排除标准
- •History opioid abuse
- •History of intractable vomiting after previous surgery
研究组 & 干预措施
Dextromethorphan
干预措施: Dextromethorphan Hydrobromide (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Post-op opioid use
时间窗: 24 hours
次要结局
- Postoperative opioid consumption(at 48 hours)
- Subjective pain(preoperatively and 6, 12, 24, and 48 hours postoperatively)
研究者
Nathanael Heckmann
Assistant Professor
University of Southern California