Investigate the Efficacy of Acupuncture in Postoperative Pain Control for Minimal Invasive Thoracoscopic Surgery Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change from baseline pain scale at post operative day 2, after intervention
研究概览
简要总结
Minimal invasive thoracoscopic surgery has been used widely for common thoracic diseases in recent years. Patients who received thoracoscopic surgery recovered much quickly and returned to their daily life sooner because of small operation wound and less invasion. However, operative pain was still an important factor, which might contribute to several post-operative complications.
In daily practice, patients received oral/intravenous form non-steroidal anti-inflammatory drugs and opioid agents, or patient-controlled analgesia for post operative pain control. However, some side effects were observed occasionally.
The role of acupuncture in post-operative pain control was frequently discussed in recent research. The main mechanisms of acupuncture in pain control were (1) to stimulate the release of endogenous opioid and (2) to block TRPV1 receptor.
The randomized controlled trial arranged by Gary Deng and his colleagues in 2008, was the first clinical trial investigated the role of acupuncture in post-operative pain control for traditional thoracotomy patients. However, there was no further research about the role of acupuncture applied to minimal invasive thoracoscopic surgery.
Thus, the aim of this randomized controlled trial was to investigate the role of acupuncture in post-operative pain control for minimal invasive thoracoscopic surgery patients. In order to deliver a safe and effective way in pain control, and to save medical cost and promote quality of patient care.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age more than 20-year-old
- •Both male and female patients
- •Nationality: Republic of China (R.O.C., Taiwan)
- •Who received thoracoscopic surgery for benign lung tumor/disease, metastatic lung tumor, primary lung cancer, mediastinal tumor
排除标准
- •Abnormal function of coagulation
- •Platelet count less than 20 x 10^3/mm^3
- •International normalized ratio (INR) more than 2.5
- •Severe comorbidity, for example central vascular, cardiovascular disease, liver/renal failure
- •Who would not cooperate in access, or express appropriately
结局指标
主要结局
Change from baseline pain scale at post operative day 2, after intervention
时间窗: measure at post-operative day 1, 9AM, before intervention; and post-operative day 2, 5PM, after intervention
1. Pain, as assessed by Numeric Rating Scale, NRS 2. Measure at post-operative day 1, 9AM, before intervention; and post-operative day 2, 5PM, after intervention 3. accompanied with rest, deep breath, cough and change posture by left and right decubitus
次要结局
- Vital signs(measure during whole admission, an average of 7 days)
- Questionnaire(measure before discharge, an average at post operative day 5)
- Opioid dosage(injection times of morphine or ketorolac would be recorded during whole admission, an average of 7 days)
- Von Frey hair Test(measure at post-operative day 1, 9AM, before intervention; and post-operative day 2, 5PM, after intervention)