CTRI/2020/05/025464已完成不适用
A prospective observational study to assess the efficacy of auricular TENS in pain relief and haemodynamics in post sternotomy cardiac surgery patients
SGPGIMS Lucknow1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2020年1月6日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Pain relief assessed every day
研究概览
简要总结
This clinical trial will evaluate the effect of transcutaneous nerve stimulation of the Vagus nerve at the site of External auricle of human subjects in lessening th epostoperative sternotomy pain in cardiac surgical patients and its role in lessenign the requirement of the opioids. Second this trial will also look into the incidence of arrythmias in postoperative cardiac patients and the effect of auricular TENS in lessening the magnitude of these arrythmias.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Post sternotomy cardiac surgery patients divided in three groups for pain relief.One group will act as control and pain management will be done as per institutional protocol.
- •Second group will have two arms.
- •one active arm will be given auricular TENS therapy and the placebo arm will have sham TENS therapy.
- •The Pain will be evaluated with established pain scoring systems and the pain relief medications will be given on the patient responce as per protocol.
- •The haemodynamic effects will be noted in all the three groups.
排除标准
- •Ejection Fraction less than 50 percent diabetes hypertension any pain syndrome refusal to take part in study ear infection or deformation.
结局指标
主要结局
Pain relief assessed every day
时间窗: three time per day
Haemodynamic assessment and incidence of arrythmia
时间窗: three time per day
Need of pain medications and dose as per patient requirement
时间窗: three time per day
次要结局
- Type of arrhythmia(duration of arrhythmia)
研究者
研究点 (1)
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