Evaluation of Intravenous Glucocorticoid Therapy in Total Knee Arthroplasty
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Pain Score
研究概览
简要总结
The purpose of this study is to evaluate if the use of two small doses of intravenous (IV) steroids around the time of knee replacement surgery decrease a patient's pain or use of pain medication. The investigators will also determine if the subjects receiving the steroid will have better pain control and better postoperative outcomes after their surgery.
详细描述
Adequate pain control after total knee arthroplasty (TKA) is of great importance not only to maximize patient comfort, but also to ensure optimal outcomes after surgery. This study is designed to assess whether the use of two small doses of intravenous (IV) steroids around the time of surgery decrease a patient's pain or use of pain medication. Secondly, the investigators will also determine if the use of these steroids as part of a multimodal pain management strategy leads to improved patient outcomes, including pain, nausea and vomiting, knee function and length of stay in the hospital after surgery. The study will compare the effect of two different doses of IV dexamethasone given preoperatively before TKA, when compared to placebo.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing primary total joint arthroplasty of the knee
- •Adult patients ages 18-100 years
- •Patients must have smart phone and/or device for app usage
排除标准
- •Current chronic steroid use
- •Patients undergoing revision knee surgery
- •Patients ambulating preoperatively with assistive devices
- •Patients with avascular necrosis of the operative knee
- •Patients with a history of an adverse reaction to glucocorticoid steroids
- •Patients unable to provide informed consent
- •Patients with inflammatory arthritis
- •Prisoners
- •Current smokers
- •Patients <18 years of age
- •Any patient with a complicated postoperative course that requires transfer to the Intensive Care Unit (ICU) or to another facility for further management will be removed from the study.
- •Any contraindication that would prevent the patient from being treated with the standard multimodal postoperative pain management regimen History of infection of surgical knee.
- •Patients with diabetes.
- •Patients that have an intolerance to Toradol.
- •Patients that do not have smart phone and/or device for app usage
研究组 & 干预措施
Placebo
Subjects undergoing primary total joint arthroplasty of the knee will receive two doses of placebo intravenously in addition to a standard multimodal postoperative pain management regimen typically used for total knee arthroplasty. The first dose of placebo will be given preoperatively within 3 hours of surgery and the second dose will be administered 8 hours after the first dose in the inpatient setting.
干预措施: Standard multimodal pain management regimen (Drug)
Placebo
Subjects undergoing primary total joint arthroplasty of the knee will receive two doses of placebo intravenously in addition to a standard multimodal postoperative pain management regimen typically used for total knee arthroplasty. The first dose of placebo will be given preoperatively within 3 hours of surgery and the second dose will be administered 8 hours after the first dose in the inpatient setting.
干预措施: Placebo (Drug)
Dexamethasone 10 mg
Subjects undergoing primary total joint arthroplasty of the knee will receive two doses of 10 mg dexamethasone. The first dose will be given preoperatively within 3 hours of surgery and the second dose will be administered 8 hours after the first dose in the inpatient setting. Additionally, subjects will also receive a standard multimodal postoperative pain management regimen typically used for total knee arthroplasty.
干预措施: Dexamethasone 10 mg (Drug)
Dexamethasone 10 mg
Subjects undergoing primary total joint arthroplasty of the knee will receive two doses of 10 mg dexamethasone. The first dose will be given preoperatively within 3 hours of surgery and the second dose will be administered 8 hours after the first dose in the inpatient setting. Additionally, subjects will also receive a standard multimodal postoperative pain management regimen typically used for total knee arthroplasty.
干预措施: Standard multimodal pain management regimen (Drug)
Dexamethasone 20 mg
Subjects undergoing primary total joint arthroplasty of the knee will receive two doses of 20 mg dexamethasone. The first dose will be given preoperatively within 3 hours of surgery and the second dose will be administered 8 hours after the first dose in the inpatient setting. Additionally, subjects will also receive a standard multimodal postoperative pain management regimen typically used for total knee arthroplasty.
干预措施: Dexamethasone 20 mg (Drug)
Dexamethasone 20 mg
Subjects undergoing primary total joint arthroplasty of the knee will receive two doses of 20 mg dexamethasone. The first dose will be given preoperatively within 3 hours of surgery and the second dose will be administered 8 hours after the first dose in the inpatient setting. Additionally, subjects will also receive a standard multimodal postoperative pain management regimen typically used for total knee arthroplasty.
干预措施: Standard multimodal pain management regimen (Drug)
结局指标
主要结局
Pain Score
时间窗: Baseline, end of hospital stay (up to 3 days), 1, 4, and 12 months post-operatively
Post-operative pain was assessed using the well-standardized and accepted visual analog pain scale. The scale shows a series of faces ranging from a happy face at 0= "No hurt", to a crying face at 10= "Hurts worst". The participant was asked to choose the face that best describes their level of pain. Higher scores indicate higher intensities of pain.
Opioid Analgesic Usage
时间窗: 1 day post-operatively
The amount of post-operative opioid analgesic usage is assessed as Oral Morphine Equivalents (OME) which is the amount of an oral morphine drug that would be necessary to equal the pain treatment from opioid morphine.
次要结局
- Soft Tissue Swelling(1 day post-operatively)
- Range of Motion (ROM)(Baseline, 1 day post-operatively, 1, 4, and 12 months post-operatively)
- Post-operative Day of Physical Therapy Clearance(Up to 3 days post-operatively)
- Blood Glucose(Baseline, Post-operative Day 1)
- 36-Item Short Form Health Survey (SF-36) Score(Baseline, 12 months post-operatively)
- Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR.) Score(Baseline, 1, 4, and 12 months post-operatively)
- Number of Participants Readmitted to the Hospital(Up to 12 months post-operatively)
- Number of Participants With Wound Infections(Up to 12 months post-operatively)
- Antiemetic Dose Administered(Post-operative Days 1 and 2)
- Length of Hospital Stay(Up to 3 days post-operatively)
研究者
Thomas L Bradbury
Associate Professor
Emory University