Effects of Perioperative Intravenous Dexamethasone on the Severity of Persistent Postsurgical Pain After Total Knee Arthroplasty : A Prospective, Randomized, Double-blind, Placebo-controlled Trial
2016年10月7日 更新者：Nitchanant Kitcharanant、Chiang Mai University
To compare the effects of perioperative intravenous Dexamethasone with a placebo on the severity of persistent postsurgical pain after total knee arthroplasty.
研究概览
详细说明
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.
研究类型
介入性
注册 (预期的)
70
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
-
ChiangMai、泰国、50200
- 招聘中
- Department of Orthopedics, Chiang Mai University
-
接触：
- Nitchanant Kitchatanant
- 电话号码：+66871071133
- 邮箱：nk_win@hotmail.com
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
40年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：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.
|
|
|
安慰剂比较：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.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Modified WOMAC scores for pain at 12 weeks postoperative
大体时间：12 weeks
|
using the modified Thai version of the Western Ontario and McMaster (WOMAC) osteoarthritis index for knee osteoarthritis questionnaire
|
12 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Visual analogue scales for pain during a five-meter walk (0-100)
大体时间：postoperatively at 24, 30, 48, 54, 72 hrs
|
postoperatively at 24, 30, 48, 54, 72 hrs
|
|
|
Visual analogue scales for pain during 45 degree active knee flexion (0-100)
大体时间：postoperatively at 6, 24, 30, 48, 54, 72 hrs
|
postoperatively at 6, 24, 30, 48, 54, 72 hrs
|
|
|
Visual analogue scales for current pain at rest in a supine position (0-100)
大体时间：postoperatively at 6, 24, 30, 48, 54, 72 hrs
|
postoperatively at 6, 24, 30, 48, 54, 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)
大体时间：postoperatively at 0-24, 24-48, 48-72 hrs
|
postoperatively at 0-24, 24-48, 48-72 hrs
|
|
|
Visual analogue scale values for nausea (0-100)
大体时间：postoperatively at 6, 24, 30, 48, 54, 72 hrs
|
postoperatively at 6, 24, 30, 48, 54, 72 hrs
|
|
|
Opioid consumption (mg.)
大体时间：during the first 0-24, 24-48, and 48-72 hrs
|
during the first 0-24, 24-48, and 48-72 hrs
|
|
|
Anti-emetic medicine consumption (mg.)
大体时间：during the first 0-24, 24-48, and 48-72 hrs
|
during the first 0-24, 24-48, and 48-72 hrs
|
|
|
Maximum degree of active knee flexion
大体时间：postoperatively at 24, 48, 72 hrs, 2 weeks, 6 weeks, and 12 weeks
|
postoperatively at 24, 48, 72 hrs, 2 weeks, 6 weeks, and 12 weeks
|
|
|
Modified WOMAC scores for pain
大体时间：postoperatively at weeks 2 and 6
|
using the modified Thai version of the Western Ontario and McMaster (WOMAC) osteoarthritis index for knee osteoarthritis questionnaire
|
postoperatively at weeks 2 and 6
|
|
Wound complications
大体时间：evaluated postoperatively at weeks 2, 6 and 12
|
evaluated postoperatively at weeks 2, 6 and 12
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Nitchanant Kitcharanant, MD、Department of Orthopedics, Faculty of Medicine, Chiang Mai University
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- 1. Callahan CM, Drake BG, Heck DA, Dittus RS. Patient outcomes following tricompartmental total knee replacement. A meta-analysis. JAMA. 1994;271(17):1349-57. 2. Grosu I, Lavand'homme P, Thienpont E. Pain after knee arthroplasty: an unresolved issue. Knee Surg Sports Traumatol Arthrosc. 2014;22(8):1744-58.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2016年10月1日
初级完成 (预期的)
2017年6月1日
研究注册日期
首次提交
2016年5月1日
首先提交符合 QC 标准的
2016年5月1日
首次发布 (估计)
2016年5月3日
研究记录更新
最后更新发布 (估计)
2016年10月10日
上次提交的符合 QC 标准的更新
2016年10月7日
最后验证
2016年10月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.