Effects of Perioperative Intravenous Dexamethasone on the Severity of Persistent Postsurgical Pain After Total Knee Arthroplasty : A Prospective, Randomized, Double-blind, Placebo-controlled Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Modified WOMAC scores for pain at 12 weeks postoperative
研究概览
简要总结
To compare the effects of perioperative intravenous Dexamethasone with a placebo on the severity of persistent postsurgical pain after total knee arthroplasty.
详细描述
It is not clear whether perioperative intravenous Dexamethasone has an effect on severity of persistent postsurgical pain (PPSP) after total knee arthroplasty (TKA). The research hypothesis is that TKA patients experience less severe PPSP after administration of perioperative 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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 40 years (45)
- •Primary knee osteoarthritis diagnosed using the American College of Rheumatology criteria (46)
- •Undergoing elective, primary and unilateral total knee arthroplasty
- •American Society of Anesthesiology (ASA) physical status class 1-3
- •BMI < 40 kg/m2
排除标准
- •History of active rheumatic diseases
- •History of previous musculoskeletal injury of the same knee for excluding patients with secondary knee osteoarthritis
- •History of previous surgery on the same knee
- •History of adverse effects from medications to be used in this study
- •Contraindication to spinal anesthesia
- •History of psychiatric disorders or cognitive impairment
- •Contraindication to corticosteroid agents
- •Poorly controlled diabetes mellitus (HbA1C > 7.5)
- •Poorly controlled hypertension
- •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 cataracts or glaucoma or ocular hypertension
- •History of steroid or immunosuppressive drug use within 6 months of surgery
研究组 & 干预措施
Dexamethasone
The steroid group will receive Dexamethasone 10 mg IV immediately prior to induction of spinal anesthesia and will receive a second and third dose of Dexamethasone 10 mg IV postoperatively at 24 and 48 hrs.
干预措施: Dexamethasone (Drug)
Placebo
The control group will receive sterile normal saline solution, serving as placebo, IV immediately prior to induction of spinal anesthesia and will receive a second and third dose of placebo IV postoperatively 24 and 48 hrs. Both Dexamethasone and normal saline solution will be administered as an IV push.
干预措施: Normal saline solution (Drug)
结局指标
主要结局
Modified WOMAC scores for pain at 12 weeks postoperative
时间窗: 12 weeks
using the modified Thai version of the Western Ontario and McMaster (WOMAC) osteoarthritis index for knee osteoarthritis questionnaire
次要结局
- Visual analogue scales for pain during a five-meter walk (0-100)(postoperatively at 24, 30, 48, 54, 72 hrs)
- Visual analogue scales for pain during 45 degree active knee flexion (0-100)(postoperatively at 6, 24, 30, 48, 54, 72 hrs)
- Visual analogue scales for current pain at rest in a supine position (0-100)(postoperatively at 6, 24, 30, 48, 54, 72 hrs)
- Visual analogue scale values for nausea (0-100)(postoperatively at 6, 24, 30, 48, 54, 72 hrs)
- Opioid consumption (mg.)(during the first 0-24, 24-48, and 48-72 hrs)
- Anti-emetic medicine consumption (mg.)(during the first 0-24, 24-48, and 48-72 hrs)
- Visual analogue scales for maximum pain at rest over the last 24 hours and minimum pain at rest over the last 24 hours (0-100)(postoperatively at 0-24, 24-48, 48-72 hrs)
- Maximum degree of active knee flexion(postoperatively at 24, 48, 72 hrs, 2 weeks, 6 weeks, and 12 weeks)
- Modified WOMAC scores for pain(postoperatively at weeks 2 and 6)
- Wound complications(evaluated postoperatively at weeks 2, 6 and 12)
研究者
Nitchanant Kitcharanant
MD
Chiang Mai University