Effects of Intraarticular IL1-Ra on Pain and Inflammatory Mediators After Knee Arhroscopy -a Double Blind, Placebo Controlled Study Using Microdialysis Technique
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Pain relief
研究概览
简要总结
This project investigates the relation between acute pain and local inflammation. Pain reported by the patients for knee arthroscopy are compared with local changes in inflammatory mediators by using microdialysis technique. Patients with moderate-to-severe pain are included in a randomized placebo-controlled trial of anakinra given intra-articularly.
详细描述
The effects of the recombinant IL-1 receptor antagonist anakinra both on acute pain and post operative inflammation will be evaluated. On inclusion, pain intensity will be measured on a five-point verbal rating scale (0= no pain, 1=mild pain, 2=moderate pain, 3=severe pain, and 4=intolerable pain), and on a visual analogue scale (0-100mm). VAS scale will be repeated at 20, 40, 60, 80, 100, 120, 140, 160, 180 and 200 minutes after inclusion / intervention. The patients will also rate pain intensity during a 5 meters walk at 200 minutes (evoked pain). The patient will rate pain at rest and evoked pain 24, 48 and 72 h after intervention.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Otherwise healthy patients (ASA 1 and 2) undergoing knee arthroscopy in general anaesthesia.
- •Being informed about and willing to participate in the study -
排除标准
- •Pregnancy or lactation. Fertile women will be asked if they may be pregnant, and offered a pregnancy test if there is doubt.
- •Established osteoarthritis or synovitis
- •Known intolerance to anakinra
- •Kidney failure (Creatinine clearance <30ml/min)
- •History of frequent infectious diseases or immunodeficiency
- •Heart failure
- •History of drug -or alcohol abuse
- •Participation in other synchronous clinical trials
- •Perioperative steroid treatment, perioperative paracetamol (12 hrs), NSAIDs (24 hrs) or COX2-inhibitors (48 hrs).
- •Use of tourniquet for bloodless field
- •Strong preoperative pain (VRS ≥3)
- •Intolerable postoperative pain (VRS=4)
研究组 & 干预措施
Anakinra
Anakinra 100 mg in 2 ml saline IA
干预措施: Anakinra 100 mg in 2 ml saline IA (Drug)
Placebo
Saline 2 ml IA
干预措施: Anakinra 100 mg in 2 ml saline IA (Drug)
结局指标
主要结局
Pain relief
时间窗: 72h
Selv reported pain
次要结局
- Resuce analgesic drug consumption(72h)
研究者
Leiv Arne Rosseland
Professor MD
Oslo University Hospital