Effect of Dexamethasone as Analgesic Treatment After Total Knee Arthroplasty: Subgroup Analyses of The DEX-2-TKA Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 485
- 试验地点
- 5
- 主要终点
- Cumulative usage of morphine 0-48 hours postoperatively
研究概览
简要总结
Effect of Dexamethasone as Analgesic Treatment After Total Knee Arthroplasty: Subgroup Analyses of The DEX-2-TKA Randomized Clinical Trial This explorative post-hoc analysis is a substudy of the DEX-2-TKA-trial (NCT03506789) investigating diffefferent subgroups of the patients included in the main trial.
详细描述
Effect of Dexamethasone as Analgesic Treatment After Total Knee Arthroplasty: Subgroup Analyses of The DEX-2-TKA Randomized Clinical Trial This explorative post-hoc analysis is a substudy of the DEX-2-TKA-trial (NCT03506789) investigating diffefferent subgroups of the patients included in the main trial.
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
- •Participation in the DEX-2-TKA-trial
排除标准
- 未提供
研究组 & 干预措施
Treatment A
24 mg dexamethasone i.v. perioperatively and 24 mg dexamethasone i.v. on the first postoperative day
干预措施: Dexamethasone (Drug)
Treatment B
24 mg dexamethasone i.v. perioperatively and placebo (isotonic saline) i.v. on the first postoperative day
干预措施: Dexamethasone (Drug)
Treatment B
24 mg dexamethasone i.v. perioperatively and placebo (isotonic saline) i.v. on the first postoperative day
干预措施: Isotonic saline (Drug)
Placebo
Placebo (isotonic saline) i.v. perioperatively and placebo (isotonic saline) i.v. on the first postoperative day
干预措施: Isotonic saline (Drug)
结局指标
主要结局
Cumulative usage of morphine 0-48 hours postoperatively
时间窗: Time Frame: 0-48 hours postoperatively
Morphine administered both as patient-controlled analgesia (PCA) i.v. morphine 0-24 hours and oral morphine on demand 24-48 hours, and any other supplemental morphine administered postoperatively. Consumption in mg
次要结局
未报告次要终点