Study on the PECS II Block With Postoperative Pain in Patients Undergoing Single Port Robot-assisted Transaxillary Thyroidectomy: Double-blinded Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Min Suk Chae
- 入组人数
- 76
- 主要终点
- Analgesic efficacy
研究概览
简要总结
The da Vinci robotic system was developed to improve both operative maneuverability (through multi-articulated instruments) and the surgical view (via a three-dimensional camera). Although the system has many advantages, skin incision, wide flap dissection, and pneumatic/mechanical retraction remain essential, but cause postoperative pain and slower recovery. Previous studies found that pectoralis fascial blocks were easy to establish; local anesthetics are injected between two adjacent myofascial layers under ultrasound guidance, providing the surgeon with a clear image. Analgesic efficacy has been validated during robotic thyroidectomy in our institution. The pain outcomes were comparable between the groups, but there were fewer complications in the PECS II group. The investigators investigated whether this block can reduce postoperative pain during wide flap dissection for single-port robot-assisted transaxillary thyroidectomy.
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 (Care Provider, Investigator)
入排标准
- 年龄范围
- 19 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 19 to 60 years who are scheduled to undergo single-port robot thyroidectomy (lobectomy or total thyroidectomy)
- •Patients with cancer stages T1 or T2 (less than 4 cm without invasion of surrounding tissue) when thyroid cancer is suspected in the preoperative examination
- •Patients with nodules with a maximum length of less than 4 cm based on ultrasonography if thyroid cancer is not suspected in the preoperative examination
- •Patients with a BMI greater than or equal to 18.5 and less than 30.0.
排除标准
- •Patients requiring lateral cervical lymph node dissection
- •pregnant women
- •Uncontrolled diabetes
- •Chronic kidney failure
- •Patients with previous neck surgery
- •Patients with Graves' disease
- •People with chronic alcoholism
- •Patients with vocal cord paralysis before surgery
- •Severe obese patients with a body mass index >35 kg/m2
- •Patients participating in another clinical trial within 30 days
- •Patients who expect that it will be difficult for medical staff to fill out the questionnaire on their own
- •Patients whose medical staff determines that participation in the study is difficult due to other underlying diseases
结局指标
主要结局
Analgesic efficacy
时间窗: the day after surgery
Visual analog scale from 0 (minimum) to 10 (maximum)
次要结局
- Quality of postoperative surgery course(the day after surgery)
研究者
Min Suk Chae
Assistant professor
Seoul St. Mary's Hospital