Role of Transcranial Direct Current Stimulation (tDCS) in Reduction of Pain and Postsurgical Opioid Consumption in Total Knee Arthroplasty (TKA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 主要终点
- Opioids consumption / 24 hours at the 1st day postoperative
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Opioids consumption / 24 hours at the 1st day postoperative
时间窗: 1st day postoperative
Measuring the consumption dose of opioids per 24 hours at the 1st day postoperative
Opioids Consumption / 24 hours at the second day postoperative
时间窗: day 2 postoperative
Measuring the consumption dose of opioids per 24 hours at the second day post-operative
Opioids consumption per 24 hours at the 4th day postoperative
时间窗: day 4 postoperative
Measuring the consumption dose of opioids per 24 hours at the fourth day
Opioids consumption / 24 hours at the third day postoperative
时间窗: day 3 postoperative
Measuring the consumption dose of opioids per 24 hours at the third day postoperative
次要结局
- Pain assessment by VAS(1st postoperative days)
- Opioid side effects(4th post operative day)
研究者
Eman M. Khedr
Clinical Professor
Assiut University