Transcranial Direct Current Stimulation for Postoperative Pain in Knee Arthroplasty (TDCSTKA)
2020年9月12日 更新者：Eman M. Khedr、Assiut University
Role of Transcranial Direct Current Stimulation (tDCS) in Reduction of Pain and Postsurgical Opioid Consumption in Total Knee Arthroplasty (TKA)
The objective of this study is to detect the effect of trans-cranial direct current stimulation on postoperative pain and opioid consumption in total knee arthro-plasty patients.
Fifty patients undergoing unilateral TKA will be randomly assigned to receive 4 sessions, total of 80 minutes of real (n=25) or sham tDCS (n=25).
Stimulation will be given on 4 consecutive postoperative days, group 1 will receive real stimulation with the active electrode over the leg representation of the motor strip (cortical motor area of the leg) and the reference electrode over the arm, group 2 will receive Sham tDCS.
Pain level will be evaluated according to visual analogue scale (VAS) and LANSS pain scale before (base line) after 1st, 2nd, 3rd and 4th sessions.
研究概览
详细说明
The study aims to to detect the effect of trans-cranial direct current stimulation on postoperative pain and opioid consumption in total knee arthro-plasty patients.
Fifty patients undergoing unilateral TKA will be randomly assigned to receive 4 sessions, total of 80 minutes of real (n=25) or sham tDCS (n=25). Stimulation will be given on 4 consecutive postoperative days, group 1 will receive real stimulation with the active electrode over the leg representation of the motor strip (cortical motor area of the leg) and the reference electrode over the arm, group 2 will receive Sham tDCS.
Pain level will be evaluated according to visual analogue scale (VAS) and LANSS pain scale before (baseline) after 1st, 2nd, 3rd and 4th sessions.
研究类型
介入性
注册 (实际的)
46
阶段
- 不适用
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
30年 至 60年 (成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Providing informed consent to participate in the study.
- age >30 years and <60 years both genders.
- ASA I to II patients.
- postoperative unilateral total knee arthroplasty.
Exclusion Criteria:
- Contraindications to transcranial brain stimulation: presence of a history of epilepsy, implantable devices (ventriculo-peritoneal shunts, pacemakers, intracranial metal implants).
- Neurological or psychiatric pathology.
- Patients taking major centrally acting drugs (anti-epileptics or antidepressants) or high-dose opioid.
- History of substance abuse.
- Severe cardio-pulmonary, renal, hepatic diseases.
- Pregnancy and lactation.
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：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Real tDCS
Direct current stimulation using anodal electrode, 25 patients received real anodal tDCS on the motor area for 20 minutes every day for 4 consecutive days.
|
25 patients received real anodal tDCS on the motor area for 20 minutes every day for 4 consecutive days.
|
|
假比较器：Sham tDCS
Sham direct current stimulation, 25 patients received sham anodal tDCS on the motor area for 20 minutes every day for 4 consecutive days.
|
25 patients received sham anodal tDCS on the motor area for 20 minutes every day for 4 consecutive days.
|
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 |
|---|---|---|
|
Opioids consumption per 24 hours at the 4th day postoperative
大体时间：day 4 postoperative
|
Measuring the consumption dose of opioids per 24 hours at the fourth day
|
day 4 postoperative
|
|
Opioids consumption / 24 hours at the third day postoperative
大体时间：day 3 postoperative
|
Measuring the consumption dose of opioids per 24 hours at the third day postoperative
|
day 3 postoperative
|
|
Opioids Consumption / 24 hours at the second day postoperative
大体时间：day 2 postoperative
|
Measuring the consumption dose of opioids per 24 hours at the second day post-operative
|
day 2 postoperative
|
|
Opioids consumption / 24 hours at the 1st day postoperative
大体时间：1st day postoperative
|
Measuring the consumption dose of opioids per 24 hours at the 1st day postoperative
|
1st day postoperative
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Opioid side effects
大体时间：4th post operative day
|
Record Opioid-related adverse effects (nausea and/or vomiting and the need for alizapride 50mg IV).
|
4th post operative day
|
|
Pain assessment by VAS
大体时间：3rd postoperative day
|
Pain Assessment using Visual Analogue Scale
|
3rd postoperative day
|
|
Pain assessment by VAS
大体时间：2nd postoperative day
|
Pain Assessment using Visual Analogue Scale
|
2nd postoperative day
|
|
Pain assessment by VAS
大体时间：1st postoperative days
|
Pain Assessment using Visual Analogue Scale
|
1st postoperative days
|
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。
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。
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
2015年6月1日
初级完成 (实际的)
2016年1月1日
研究完成 (实际的)
2016年1月1日
研究注册日期
首次提交
2016年1月31日
首先提交符合 QC 标准的
2016年3月8日
首次发布 (估计)
2016年3月9日
研究记录更新
最后更新发布 (实际的)
2020年9月16日
上次提交的符合 QC 标准的更新
2020年9月12日
最后验证
2020年9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.
膝关节置换术的临床试验
tDCS的临床试验
-
Universidad de AlmeriaSecretaría General de Universidades, Investigación y Tecnología, Junta de Andalucía, Spain邀请报名
-
University of North Carolina, Chapel HillNational Institute of Mental Health (NIMH)完全的
-
Northeastern UniversityMassachusetts General Hospital; National Institute on Aging (NIA)未知
-
University of California, Los AngelesNational Institute of Mental Health (NIMH)完全的
-
Charite University, Berlin, GermanyPhysikalisch-Technische Bundesanstalt Institut Berlin (PTB)完全的
-
Charite University, Berlin, GermanyPhysikalisch-Technische Bundesanstalt Institut Berlin (PTB)完全的