Dexamethasone in Total Knee Arthroplasty: What Dose Should we be Giving Patients Intraoperatively
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 438
- 试验地点
- 15
- 主要终点
- Opioid consumption
研究概览
简要总结
The purpose of this study is to determine the most efficacious and safest dexamethasone dose given intraoperatively during total knee arthroplasty that reduces postoperative opioid consumption and pain, improves postoperative nausea and vomiting, and minimizes postoperative complications.
详细描述
Study design: Prospective randomized controlled trial
Scientific Background: In contemporary total joint arthroplasty (TJA), multimodal anesthesia and analgesia is used to improve postoperative pain, reduce opioid consumption, and minimize complications after surgery such as postoperative nausea and vomiting.1-3 Multiple medications with varying mechanisms of action are used at different time points throughout the perioperative period to modulate different pain receptors. Corticosteroids are a medication commonly utilized intraoperatively as part of contemporary multimodal protocols.
Corticosteroids are frequently used in TJA due to their potent anti-inflammatory and anti-emetic properties. Several studies have demonstrated that corticosteroids reduce postoperative nausea and vomiting as well as postoperative pain and opioid consumption.4-6 However, the optimal medication, dose, and number of doses of corticosteroid that should be administered in the perioperative period remain unknown. In addition, it remains unclear if corticosteroids can be safely used in patients with diabetes mellitus or if corticosteroids increase the risk of postoperative complications such as periprosthetic joint infection. Thus, the purpose of our study is to determine the most efficacious and safest dose of corticosteroids that should be administered intraoperatively during TJA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- 是
入选标准
- •Age > 18 years
- •Primary total knee arthroplasty
- •Patients staying at least one night in the hospital after surgery
排除标准
- •Same day discharge Age < 18 years Revision or partial total knee arthroplasty Corticosteroid use within 3 months prior to surgery Inflammatory arthritis Current systemic fungal infection Renal or liver failure Prior adverse reaction to corticosteroid Primary TKA requiring hardware removal
研究组 & 干预措施
Group 1
4mg intravenous dexamethasone, administered shortly after induction of anesthesia
干预措施: Dexamethasone 4mg (Drug)
Group 3
16mg intravenous dexamethasone, administered shortly after induction of anesthesia
干预措施: Dexamethasone 16mg (Drug)
Group 2
8mg intravenous dexamethasone, administered shortly after induction of anesthesia
干预措施: Dexamethasone 8 Mg/mL Injectable Suspension (Drug)
结局指标
主要结局
Opioid consumption
时间窗: 48-hours postoperative (after surgical intervention)
48 hours of cumulative opioid consumption measured in oral morphine equivalents
Opioid Consumption
时间窗: 48-hours postoperative (after surgical intervention)
48 hours of cumulative opioid consumption measured in oral morphine equivalents
次要结局
- Postoperative pain scores at rest and with activity(Immediately after surgical intervention (TKA) for days 1 through 7 after surgery)
- Postoperative nausea and vomiting(Immediately after surgical intervention (TKA) for days 1 through 7 after surgery. Using numeric rating scale.)
- Postoperative Blood glucose levels and insulin use(Immediately following surgical intervention until discharge from hospital (up to 30 days after surgery if still in hospital))
- Length of stay(immediately following surgery (intervention), number of days spent in the hospital after surgery to discharge, up to 30 days after intervention)
- Sleeplessness/insomnia(Immediately after surgical intervention (TKA) for days 1 through 7 after surgery, recording 24 hour sleep patterns)
- Number of participants with complications (such as readmission to hospital) up to 30 days after surgical intervention(<30 days after surgical intervention, document any readmissions to the hospital or complications that occur within 30 days from the day of surgery)
- Postoperative Pain Scores at Rest(assessed at days 1 through 7 after surgery, Day 7 reported)
- Postoperative Nausea(assessed at days 1 through 7 after surgery, Day 7 reported)
- Postoperative Blood Glucose Levels Without Diabetes(Glucose levels taken the morning after surgery)
- Postoperative Blood Glucose Levels With Diabetes(Glucose levels taken the morning after surgery)
- Number of Hours Slept Post Op Day 1(Post op day 1, recording of hours slept)
- Number of Hours Slept Post Op Day 2(Post op day 2, hours slept)
- Number of Hours Slept Post Op Day 3(Post op day 3, hours slept)
- Number of Hours Slept Post Op Day 4(Hours slept on POD 4)
- Number of Hours Slept Post Op Day 5(Hours slept on POD 5)
- Number of Hours Slept Post Op Day 6(Hours slept on POD 6)
- Number of Hours Slept Post Op Day 7(Hours slept on POD 7)
- Number of Participants With Complications up to 30 Days After Surgical Intervention(<30 days after surgical intervention, document any readmissions to the hospital or complications that occur within 30 days from the day of surgery)
研究者
Craig J Della Valle, MD
Professor of Orthopedic Surgery, Chief Division of Adult Reconstruction
Rush University Medical Center