Investigating the Efficacy of Low Dose Steroids in Reducing Postoperative Pain and Improving Sleep Quality Following Primary Total Knee Arthroplasty: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 1) To assess the effectiveness of low-dose steroids in reducing postoperative pain and local warmth following primary TKA.
研究概览
简要总结
Total knee arthroplasty (TKA) is a common surgical procedure for patients with advanced knee arthritis. Despite advancements in surgical techniques and postoperative care, pain management remains a significant challenge in the immediate postoperative period. Sleep disturbances are also prevalent following TKA, further impacting patients’ recovery and overall well-being. This randomized controlled trial (RCT) aims to evaluate the potential benefits of low-dose steroids in reducing postoperative pain and improving sleep quality among patients undergoing primary TKA.
Eligible participants will be randomized into two groups, 50 patients in each arm: the intervention group receiving low-dose steroids (Deflazacort 6mg orally) for 3 weeks postoperatively and the control group receiving placebo. Both groups will receive standard perioperative pain management protocols. The warmth over the knee will be analysed using Thermographic camera. Inflammatory parameters will be analysed using erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) and Interleukin-6 (IL-6). Pain scores will be assessed using a standardized pain scale (e.g., Visual Analog Scale) at regular intervals postoperatively. Sleep quality will be assessed using validated sleep questionnaires (e.g., Pittsburgh Sleep Quality Index).
We hypothesize that patients receiving low-dose steroids will experience lower postoperative pain scores, reduced warmth and improved sleep quality compared to those receiving placebo. Positive outcomes from this study could lead to the implementation of low-dose steroid therapy as a standard adjunctive treatment in the postoperative management of patients undergoing primary TKA, potentially improving overall patient satisfaction and enhancing recovery. This randomized controlled trial aims to investigate the efficacy of low-dose steroids in reducing postoperative pain and improving sleep quality following primary TKA. By addressing these critical aspects of postoperative care, this study has the potential to contribute valuable insights to optimize patient outcomes and enhance the quality of care in this patient population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 45.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •adult patients aged 45-80 years with a diagnosis of advanced knee osteoarthritis requiring total knee arthroplasty.
排除标准
- •Exclusion criteria will include patients with rheumatoid arthritis, contraindications to steroid use, history of chronic steroid therapy, and significant comorbidities impacting pain perception and sleep quality.
结局指标
主要结局
1) To assess the effectiveness of low-dose steroids in reducing postoperative pain and local warmth following primary TKA.
时间窗: At baseline preoperatively, postoperative day 3, 1 month, 3 months and 6 months postoperatively.
2) To evaluate the impact of low-dose steroids on sleep quality in the postoperative period after primary TKA.
时间窗: At baseline preoperatively, postoperative day 3, 1 month, 3 months and 6 months postoperatively.
次要结局
- To determine any adverse effects associated with the use of low-dose steroids in this patient population.(At baseline preoperatively, postoperative day 3, 1 month, 3 months and 6 months postoperatively.)