The Effect of Physical Thoracic Stabilization on Pain Control in Patients Who Had a Lung Tumor and Received Video-assisted Thoracoscopic Surgery: A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Visual analog scale(VAS)
研究概览
简要总结
Background: Post-video-assisted thoracic surgery (VATS) pain remains an open issue, though most patients experience less acute pain after VATS than thoracotomy. So far, there was no gold standard regarding pain control post-VATS.
Objective: To conduct a randomized controlled trial assessing the effect of physical thoracic stabilization on post-VATS pain control.
Method: The investigators aimed to recruit 40 patients with operable lung cancer in the outpatient clinic from January to December 2021. The patients will be randomized into the intervention or control group. The intervention group will receive physical thoracic stabilization with POSTHORAX ThoraxBelt after the surgery, whereas the control group will have standard care. The follow-up period will last for 6 months.
详细描述
The study has been approved by the hospital research ethics committee.
Arm 1: Physical thoracic stabilization with ThoraxBelt after VATS Arm 2: Standard care after VATS
Primary outcome: Visual analog scale (VAS) 6 hours, 24 hours, and 48 hours after the surgery.
Secondary outcomes:
- The accumulated dose of the intervenous patient-controlled analgesic drug.
- The dose of oral painkiller administered during the hospital stay.
- Complications related to the ThoraxBelt.
- Hospital stay
- VAS before discharge
- Unanticipated events (ICU admission, a second surgery, death)
- VAS during the 2-week, 1-month, 2-month, 6-month outpatient clinic visit after the surgery.
- Compliance on ThoraxBelt.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
The surgeon will not know the patients' group before or during the surgery. The outcome assessor won't know the group during the whole research.
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
- •Operable lung cancer
- •Eligible for video-assisted thoracoscopic surgery
排除标准
- •Known allergy to ThoraxBelt
- •Chest wall Infection or other diseases
- •Pregnancy
结局指标
主要结局
Visual analog scale(VAS)
时间窗: 48 hours
A pain score will be assigned to each patient after the total amount of visual analog scale. The minimum is 0 and the maximum is 10, which 10 indicated the most pain.
次要结局
- Length of hospital stay(1 month)
- IV PCA dose(48 hours)
- Complications during hospital stay(48 hours)
- The number of unanticipated events(1 month)
- On-request oral painkiller dose(48 hours)
- Visual analog scale in outpatient clinic follow-up(6 months)
- Compliance of ThoraxBelt after discharge(2 months)