Methylprednisolone Taper After Total Knee Replacement: A Prospective Randomized Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 2
- 主要终点
- Changes in Nausea score during Follow Up Period
研究概览
简要总结
Total knee replacement surgery is a commonly performed and widely successful surgery to improve mobility and decrease pain in patients suffering from severe knee arthritis. However, in the immediate period after knee replacement, patients often experience significant pain and nausea, which can limit early recovery after surgery. Glucocorticoids are anti-inflammatory drugs that can reduce pain and swelling by blocking the inflammatory process, and have already shown promise in various surgical settings, including after knee replacement. There are different glucocorticoid formulations available, and in this particular study, we are evaluating the effects of administering a Medrol Dose Pak, which is a commonly available glucocorticoid taper that is administered over a short period of time after surgery. Our hypothesis is that the administration of the Medrol Dose Pak will lead to decreased pain, nausea, and opioid consumption in the weeks following total knee replacement.
详细描述
The study aims to evaluate the efficacy of a post-operative course of glucocorticoids on pain, range of motion, and extremity function after total knee replacement surgery. The goal is to compare the effects of a Medrol dose pak administration to the standard of care, which includes a single intraoperative dose of 10 mg intravenous dexamethasone, on postoperative outcomes. The study is important in the field because it aims to evaluate the effectiveness of glucocorticoids in reducing pain, nausea, and opioid consumption following total knee replacement surgery. The study will provide valuable insight into the role and optimal dosing of oral glucocorticoids after total knee replacement surgery (TKA). The results of this study could potentially improve postoperative outcomes for patients undergoing TKA. The study population in this randomized control trial consists of patients undergoing total knee replacement surgery. Patients will be randomly assigned to one of two treatment arms: (1) a single intraoperative dose of 10 mg intravenous dexamethasone (control group) or (2) a single intraoperative dose of 10 mg intravenous dexamethasone followed by a 6-day oral methylprednisolone taper course. The study does not mention any populations of increased concern. The study will last approximately 6 months with encounters at normal times within the clinic. The Emory r extremity surgeons will personally contact all patients for 1-day post-operation (standard of care for them) and at 7-10 days. Recruitment will occur at Emory University Orthopaedics & Spine Hospital. The study team will enroll 100 patients per group - 200 total.
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
- None
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing primary total knee arthroplasty for osteoarthritis of the knee.
- •Patients of the ages of 18 and 95 years.
排除标准
- •Patients with concurrent and significant injuries to other bones or organs.
- •Minors unable to consent for participation in the study.
- •Subjects who, in the opinion of the investigator, may be non-compliant with study schedules or procedures.
- •Patients with pre-existing immune suppression, where further immune suppression with glucocorticoids could warrant unwarranted or unneeded risk.
研究组 & 干预措施
Experimental Group: Medrol Dose
The perioperative Medrol dose treatment will consist of a course that lasts six days, with 24 milligrams administered on the first day, 20 milligrams on the second day, 60 milligrams on the third day, 12 milligrams on the fourth day, 8 milligrams on the fifth day, and 4 milligrams on the sixth day. Patients will then be followed up at the clinic for six weeks following their procedure to allow for clinical evaluation and to measure outcome variables.
干预措施: Methylprednisolone (Drug)
Control Group: Standard of Care
Patients in this group will receive a single intraoperative dose of 10 mg intravenous dexamethasone (control group, IV dexamethasone is standard of care).
干预措施: Standard of Care (Other)
结局指标
主要结局
Changes in Nausea score during Follow Up Period
时间窗: Immediately after the surgery, day 1, day 2, day 3, day 4, day 5, day 6 and day 7 post-surgery
: A nausea assessment will be assessed at each post-operative visit via the Visual Analog Nausea Scale (VAS-nausea), which is ranked from 0 (no nausea) to 10 (highest amount of nausea). Patients will be asked to fill out the VAS-nausea each day until post-operative day 7. Patients will also be monitored for post-operative vomiting.
Changes in Pain Score during Follow up period
时间窗: Immediately after the surgery, day 1, day 2, day 3, day 4, day 5, day 6 and day 7 post-surgery
A pain assessment will be assessed at each post-operative visit via the Visual Analog Pain Scale (VAS-pain), which is ranked from 0 (no pain) to 10 (highest amount of pain). Pain will be assessed at rest and during active movement of extremity. Patients will also be asked to fill out the VAS-pain score each day until post-op day 7.
次要结局
- Changes in post operative knee function utilizing Knee injury and Osteoarthritis Outcome Score (KOOS)(Day 1, day 2, day 3, day 4, day 5, day 6 and day 7 post-surgery)
- Changes in the postoperative range of motion following total knee arthroplasty (TKA)(Immediately before the surgery, Immediately after the surgery, day 1, day 2, day 3, day 4, day 5, day 6 and day 7 post-surgery)
- Compare patient satisfaction with acute postoperative pain control(Immediately after the surgery, day 1, day 2, day 3, day 4, day 5, day 6 and day 7 post-surgery)
- Compare the postoperative opiate consumption measured as the number of tablets taken(Immediately after the surgery, day 1, day 2, day 3, day 4, day 5, day 6 and day 7 post-surgery)
研究者
Ajay Premkumar
Assistant Professor
Emory University