The Effect of Intravenous Single-dose Dexamethasone on Pain After Total Knee Replacement Surgery
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- pain during walking, NRS 0-10
研究概览
简要总结
The purpose of this study is to examine, if a single-dose of dexamethasone given during the operation, alleviates pain after knee replacement surgery.
详细描述
The purpose of this study is to examine, if a single-dose of dexamethasone given during the operation, alleviates pain after knee replacement surgery. This is also a dose-finding study comparing two doses of dexamethasone.
Total knee arthroplasty causes considerable pain. Multimodal analgesia and peripheral nerve blocks are used for treatment of pain. Some studies suggest that glucocorticoids alleviate postoperative pain. The optimal dose of dexamethasone in treatment of postoperative pain is not known. Studies on this subject in patients with total knee replacement are sparse. Potential side-effects of dexamethasone (hyperglycemia, wound infection) need to be studied.
Patients coming for primary knee replacement surgery are enrolled. The patients in each study group receive multimodal therapy for postoperative pain: etoricoxib, paracetamol, gabapentin and oxycodone. A single dose of intravenous dexamethasone (0,15 mg/kg or 0,25 mg/kg) or a placebo (saline) is administered to the patient during the operation. The effect of dexamethasone on postoperative pain is observed: main outcome is dynamic pain at 24 h postoperatively. The extent of inflammatory reaction is measured (CRP). Serial blood glucose measurements are done.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •primary total knee replacement surgery
- •ASA (american society of anesthesiologists) class 1-3
排除标准
- •severe coronary artery disease, heart failure, kidney failure
- •insulin-dependent DM (diabetes mellitus), poorly controlled type II DM
- •gastric/duodenal ulcer
- •allergy/contra-indication for any drug used in the study
- •corticosteroid use during last 3 months
- •preoperative use of opioid drugs (excl. codeine, tramadol)
- •neuropathy/sensory impairment of lower limbs
- •lack of co-operation, e.g. inability to use a PCA (patient controlled analgesia)-device
研究组 & 干预措施
dexamethasone 0,15 mg/kg
single-dose intravenous dexamethasone 0,15 mg/kg, intraoperative
干预措施: Dexamethasone (Drug)
dexamethasone 0,25 mg/kg
single-dose intravenous dexamethasone 0,25 mg/kg, intraoperative
干预措施: Dexamethasone (Drug)
Sodium Chloride, (24)NaCl 0,9%
single-dose intravenous saline, intraoperative
干预措施: Sodium Chloride, (24)NaCl 0,9% (Drug)
结局指标
主要结局
pain during walking, NRS 0-10
时间窗: at 24 hours postoperatively
NRS (numerical rating scale: 0=no pain, 10 = worst possible pain)
次要结局
- general wellbeing, NRS 0-10(postoperatively: at 2 hours, at 8 hours,at 24 hours, at 32 hours, at 48 hours)
- nausea, NRS 0-10(postoperatively: at 2 hours, at 8 hours,at 24 hours, at 32 hours, at 48 hours)
- pain during walking, NRS 0-10(preoperatively, postoperatively: at 8 hours, at 48 hours, seventh postoperative day)
- vomiting, yes/no(postoperatively: at 2 hours, at 8 hours,at 24 hours, at 32 hours, at 48 hours)
- consumption of intravenous oxycodone, milligrams/kilogram body weight(postoperatively: at 2 hours, at 8 hours, at 24 hours, at 48 hours)
- quality of sleep, NRS 0-10(postoperatively at 24 hours, at 48 hours)
- time to achieve discharge criteria, hours(postoperatively: at 24 hours, at 48 hours, at 72 hours, at 96 hours)
- pain at rest, NRS 0-10(preoperatively, postoperatively: at 2 hours, at 8 hours,at 24 hours, at 32 hours, at 48 hours, seventh postoperative day)