Preoperative Intraarticular Injection of Methylprednisolone in Patients Scheduled for Total Knee-arthroplasty
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Pain
研究概览
简要总结
Despite improvements in analgesic treatment following total knee arthroplasty (TKA) for osteoarthrosis, a substantial part of patients still have severe acute pain after surgery. It has been suggested that preoperative degree of intraarticular inflammation is associated to postoperative degree of pain and level of function. Furthermore it is known, that patients with preoperative inflammation have hyperalgesia and severe movement related pain.
The aim of this study is to investigate the effect of a preoperative intraarticular injection of Methylprednisoloneacetate in reducing acute postoperative pain after total knee arthroplasty in patients with signs of severe pre-operative inflammation and pain.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 50 -80
- •Osteoarthrosis
- •Scheduled for primary unilateral TKA
- •Preoperative pain report with NRS > 5 upon walking
- •Signs of sensitisation in knee
排除标准
- •Allergies to methylprednisoloneacetate, lidocaine or standard analgesic treatment
- •Deficient written or spoken danish
- •Impairment from psychological or neurological disease
- •Local og systemic infection
- •Immunodeficiency
- •Treatment with corticosteroid within 30 days of inclusion
- •Insulin treated diabetes mellitus
- •Anticoagulant therapy
- •ASA (American Society of Anaesthesia) class > 3
- •General anaesthesia
- •Alchohol use > 21 units / week
- •Pregnancy
研究组 & 干预措施
Methylprednisoloneacetate
Administration of:
1 ml methylprednisoloneacetate 40 mg/ml 5 ml lidocaine 20 mg/ml 4 ml sodium chloride 9 mg/ml as a single intraarticular injection 7 days prior to surgery.
干预措施: Methylprednisoloneacetate (Drug)
Methylprednisoloneacetate
Administration of:
1 ml methylprednisoloneacetate 40 mg/ml 5 ml lidocaine 20 mg/ml 4 ml sodium chloride 9 mg/ml as a single intraarticular injection 7 days prior to surgery.
干预措施: Lidocaine (Drug)
Methylprednisoloneacetate
Administration of:
1 ml methylprednisoloneacetate 40 mg/ml 5 ml lidocaine 20 mg/ml 4 ml sodium chloride 9 mg/ml as a single intraarticular injection 7 days prior to surgery.
干预措施: sodium chloride (Other)
Sodium chloride
Administration of:
5 ml lidocaine 20 mg/ml 5 ml sodium chloride 9 mg/ml as a singe intraarticular injection 7 days prior to surgery.
干预措施: Lidocaine (Drug)
Sodium chloride
Administration of:
5 ml lidocaine 20 mg/ml 5 ml sodium chloride 9 mg/ml as a singe intraarticular injection 7 days prior to surgery.
干预措施: sodium chloride (Other)
结局指标
主要结局
Pain
时间窗: 24 hours postoperatively
Pain intensity on a numeric rang scale (NRS) from 0 to 10 upon ambulation 24 hours following surgery
次要结局
- Sensitisation(On day 0 and day 2)
- Pain(From day 1 to day 14)
- Inflammation(On day 0)
研究者
Iben Engelund Luna
MD, Research Fellow
Rigshospitalet, Denmark