Effect of Preoperative Intravenous Dexamethasone on Postoperative Pain After Primary Total Hip Arthroplasty : A Prospective, Double-blind, Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Visual analogue scales for pain during five-metre walking (0-100)
研究概览
简要总结
To compare the effects of preoperative intravenous Dexamethasone between 10 mg and 40 mg with placebo on Postoperative Pain After Primary Total Hip Arthroplasty
详细描述
It still unclear whether the effective dose preoperative intravenous dexamethasone on postoperative pain after Total Hip Arthroplasty. The research hypothesis is that the effect of 10 mg intravenous Dexamethasone in postoperative pain(5 metre walking at 24 hour) is not inferior to 40 mg intravenous Dexamethasone
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age > 18 years
- •Undergoing Elective, Primary, unilateral Total Hip arthroplasty
- •American Society of Anesthesiology (ASA) physical class 1-3
- •BMI < 40 kg/m2
排除标准
- •History of previous musculoskeletal injury on the same hip
- •History of prior surgery on the same unilateral hip
- •History of adverse effects from medication utilized in this study
- •Contraindication to spinal anesthesia
- •History of psychiatric disorders or cognitive impairment
- •Contraindication to Corticosteroid
- •Poorly controlled Diabetes mellitus
- •History of ischemic heart disease or peripheral arterial disease or cerebrovascular disease
- •Hepatic insufficiency (Child-Pugh score > 5)
- •Renal insufficiency (Creatinine clearance < 30 mL/min)
- •History of cataract or glaucoma or ocular hypertension
研究组 & 干预措施
Normal Saline Solution
The control group receive sterile normal saline solution, as placebo, intravenous immediately prior to induction of spinal anesthesia .
干预措施: Normal Saline Solution (Drug)
10 mg Dexamethasone
The steroid group will receive Dexamethasone 10 mg IV immediately prior to induction of spinal anesthesia
干预措施: Dexamethasone (Drug)
40 mg Dexamethasone
The steroid group will receive Dexamethasone 40 mg IV immediately prior to induction of spinal anesthesia
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Visual analogue scales for pain during five-metre walking (0-100)
时间窗: at 24 hours postoperatively
Each pain outcome will be assessed using a visual analogue scale of 0-100 mm, in which 0 indicates no pain and 100 indicates the worst pain;
次要结局
- Visual analogue scales for pain during five-metre walking (0-100)(Postoperative at 48,72 hours.)
- Visual analogue scales for current pain at rest on supine position (0-100)(Postoperative at 6,24,48,72 hours.)
- Visual analogue scales for the maximal pain at rest over the last 24 hours and the minimal pain at rest over the last 24 hours (0-100)(Postoperative at 0-24,24-48,48-72 hours.)
- Visual analogue scales for pain on 45 degree active hip flexion (0-100)(Postoperative at 24,48,72 hours.)
- Visual analogue scales for nausea (0-100)(Postoperative at 6,24,48,72 hours)
- Opioid consumption (mg.)(Postoperative at 0-24,24-48,48-72 hours)
- Anti-emetic medicine consumption (mg.)(Postoperative at 0-24,24-48,48-72 hours)
- Wound complication(Postoperative at Discharge, 2 weeks, 6 weeks, 12 weeks.)
研究者
Nitchanant Kitcharanant
Effect of Preoperative Intravenous Dexamethasone on Postoperative Pain After Primary Total Hip Arthroplasty : A prospective, double-blind, randomized controlled trial
Chiang Mai University