Prospective Randomized Controlled Trial Comparing Different Doses of Corticosteroids in Local Infiltration Analgesia (LIA) for Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Visual Analog Scale (VAS) Pain Score
研究概览
简要总结
This study aims to compare the efficacy of different doses of glucocorticoids in local infiltration analgesia (LIA) during total knee arthroplasty (TKA) through a prospective single-center randomized controlled trial, and to explore the safety and feasibility of high-dose glucocorticoids. Through this research, the investigators hope to provide an optimized solution for post-TKA pain management, improve patients' postoperative recovery and quality of life, and offer scientific evidence for pain management following TKA.
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
- •Male or female participants aged 18 years or older;
- •Undergoing primary unilateral total knee arthroplasty (TKA)for unilateral knee osteoarthritis(OA)at ourhospital;
- •Preoperative American Society of Anesthesiologists(ASA)physical status classification of 1-3;
- •Ability to provide informed consent and sign a written informed consent form.
排除标准
- •Previous surgery on the operative knee or a history of infection in the operative knee;
- •Non-osteoarthritis conditions (including rheumatoid arthritis, traumatic arthritis, septic arthritis, and hemophilic arthritis);
- •Severe osteoarthritis (including flexion contracture >30° or varus/valgus deformity >30°);
- •Allergy to the relevant study drugs;
- •Presence of neuromuscular dysfunction in the ipsilateral limb;
- •Dependence on anesthetic drugs (defined as weekly use of opioids exceeding 100 mg morphine equivalents or local anesthetics for preoperative pain control for more than 3 months);
- •Poor systemic condition, including but not limited to: glycated hemoglobin (HbA1c) level >12%; blood pressure >170/110 mmHg (1 mmHg = 0.133 kPa); history of myocardial infarction, stroke, transient ischemic attack, acute congestive heart failure, or any acute coronary event within 6 months; dialysis or renal transplantation; pregnancy or lactation.
研究组 & 干预措施
High-dose group
LIA with the addition of 3 vials of Diprospan (each vial contains betamethasone 5 mg + betamethasone dipropionate 2 mg)
干预措施: LIA with different doses of Diprospan (Drug)
Medium-dose group
LIA with the addition of 2 vials of Diprospan (each vial contains betamethasone 5 mg + betamethasone dipropionate 2 mg)
干预措施: LIA with different doses of Diprospan (Drug)
Low-dose group
LIA with the addition of 1 vial of Diprospan (each vial contains betamethasone 5 mg + betamethasone dipropionate 2 mg)
干预措施: LIA with different doses of Diprospan (Drug)
Control group
LIA without the addition of Diprospan
结局指标
主要结局
Visual Analog Scale (VAS) Pain Score
时间窗: Preoperatively (baseline), and at 6 hours, 12 hours, 24 hours, 48 hours, 3 weeks, and 6 weeks postoperatively.
VAS ranges from 0 (no pain) to 10 (worst pain imaginable). Higher scores indicate worse pain.
次要结局
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score(Preoperatively, and at 3 weeks and 6 weeks postoperatively.)
- range of motion(Preoperatively, and at 3 weeks and 6 weeks postoperatively.)
- Total Postoperative Analgesic Consumption(Within the first 48 hours postoperatively)
- . C-reactive Protein (CRP) Concentration(Postoperative Day 1, Day 4, Week 3, and Week 6.)
- Erythrocyte Sedimentation Rate (ESR)(Postoperative Day 1, Day 4, Week 3, and Week 6.)
- interleukin-6(IL-6)(Postoperative Day 1, Day 4, Week 3, and Week 6.)
- Alanine Aminotransferase (ALT) Concentration(Postoperative Day 1, Day 4, Week 3, and Week 6.)
- Aspartate Aminotransferase (AST) Concentration(Postoperative Day 1, Day 4, Week 3, and Week 6.)
- Serum Creatinine Concentration(Postoperative Day 1, Day 4, Week 3, and Week 6.)
- Blood Urea Nitrogen (BUN) Concentration(Postoperative Day 1, Day 4, Week 3, and Week 6.)
- Incidence of Local Complications(0-6 months postoperatively)
- Incidence of Systemic Complications(0-6 months postoperatively)