Effects of Perioperative Intravenous Dexamethasone in Clinical Outcomes After Total Knee Arthroplasty in a Hispanic Population: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- POD 1 Visual Analogue Scale Pain Scores
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of an intravenous (IV) perioperative dexamethasone regime in the clinical outcomes after a robotic-assisted Total Knee Arthroplasty (TKA) in a Hispanic population. The study aims to propose an alternative to opioid-based pain treatment following TKA. The study hopefully validates the use of a two-dose, 8mg intravenous dexamethasone regimen for improving pain and range of motion scores in patients undergoing primary, unilateral TKA for osteoarthritis. One dose will be applied prior to incision and the other at post-operative day (POD) 1.
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
- Single (Investigator)
入排标准
- 年龄范围
- 24 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with Hispanic self-identification
- •Primary robotic-assisted TKA for treatment of primary osteoarthritis
- •Receiving seven days of inpatient rehabilitation after medical discharge
- •Patient with adequate glycemic control (HbA1c<7.5%)
- •Patients who provide written informed consent
排除标准
- •Chronic steroid use prior to surgery
- •Previous allergies or adverse reactions to steroid drugs
- •Indications for surgery other than primary osteoarthritis
- •History of narcotics abuse such as opioids
- •Surgeries performed without robotic-assistance
- •Outpatient or Home rehabilitation programs after medical discharge
- •Requirement of revision surgery orthopaedic implants
- •Patients with inadequate glycemic control (HbA1c≥7.5%)
- •Other medical conditions, such as osteoporosis, fungal infections, glaucoma, joint infections, peptic ulcer disease which could worsen with steroid administration.
研究组 & 干预措施
Patients receiving intravenous dexamethasone
干预措施: Dexamethasone (Drug)
Patients receiving intravenous morphine and oral oxycodone
干预措施: Morphine (Drug)
Patients receiving intravenous morphine and oral oxycodone
干预措施: Oxycodone and acetaminophen (Drug)
结局指标
主要结局
POD 1 Visual Analogue Scale Pain Scores
时间窗: Measured at 7:00AM day after surgery
Range: 0-10 (10 indicates highest degree of pain)
POD 2 Visual Analogue Scale Pain Scores
时间窗: Measured at 7:00AM two days after surgery
Range: 0-10 (10 indicates highest degree of pain)
POD 3 Visual Analogue Scale Pain Scores
时间窗: Measured at 7:00AM three days after surgery
Range: 0-10 (10 indicates highest degree of pain)
POD 1 Range of Motion
时间窗: Measured at 7:00AM the day after surgery
POD 2 Range of Motion
时间窗: Measured at 7:00AM two days after surgery
POD 3 Range of Motion
时间窗: Measured at 7:00AM three days after surgery
次要结局
- Daily Dextrose Concentration (mg/dL)(Measured at 7:00AM for 3 days after surgery)
- Length of Stay(From hospital admission to the date of discharge (About 3 days))