The Management and Assessment of Pain Control in Rib Fracture With Non-invasive Stabilization: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 112
- 试验地点
- 2
- 主要终点
- Inpatients: Visual analog scale (VAS)
研究概览
简要总结
Brief summary:
Background: Rib fractures are one of the most common causes of trauma disabilities and have become an important health issue. Patients usually suffer from severe pain. A rapid and adequate pain control is considered as a priority to improve respiratory mechanics and reduce the risk of pulmonary and systemic complications. So far, there was no gold standard regarding pain control for rib fractures.
Objective: To assess the effect of the newly-designed Prosthorax Thoraxbelt in addition to oral analgesics on pain control of rib fractures
Method: There will be two groups of patients in this study. One group will be the patients with rib fractures who are necessary for in-hospital intense pain control. The other will consist of follow-up patients with rib fractures at an outpatient clinic. The investigators will aim to recruit 30 and 82 patients respectively.
详细描述
The study has been approved by the hospital research ethics committee.
Arm1: The management and assessment of pain control in rib fracture with non-invasive stabilization: a randomized controlled trial (inpatients)
Arm2: The management and assessment of pain control in rib fracture with non-invasive stabilization: a randomized controlled trial (outpatients)
Primary outcome:
- inpatient: Visual analog scale (VAS) for 6 hours, 12 hours and 24 hours after the surgery
- outpatient: Visual analog scale (VAS) for the times at emergency room; 3 days, 3 weeks and 3 months after rib fracture at an outpatient clinic.
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
- Double (Care Provider, Outcomes Assessor)
盲法说明
The surgeon will not know the patients' group before or during the surgery. The outcome assessor will not 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
- •The adult patients with rib fractures (inpatients/outpatients)
- •The patients will be assessed to the further admission (inpatients)
- •The patients will be assessed to be at follow-up clinic visit (outpatients)
排除标准
- •The accident of rib fractures has been occurred over 24 hours. (inpatients/outpatients)
- •Refuse to be arranged to the admission (inpatients)
- •Refuse to receive the CT scan (inpatients/outpatients)
- •Chest wall infection or other diseases (inpatients/outpatients)
- •Chest wall infected by rumors (inpatients/outpatients)
- •Pregnancy (inpatients/outpatients)
- •Further complications arise (inpatients/outpatients)
- •Known allergy to ThoraxBelt (inpatients/outpatients)
结局指标
主要结局
Inpatients: Visual analog scale (VAS)
时间窗: 48 hours
A pain score will be assessed to each patient after the total amount of visual analog scale. The minimum is 0 and the maximum is 10, from the least pain to the highest pain.
Outpatients: Visual analog scale (VAS)
时间窗: 3 months
A pain score will be assessed to each patient after the total amount of visual analog scale. The minimum is 0 and the maximum is 10, from the l
次要结局
- Inpatients: On-request oral painkiller dose(48 hours)
- Inpatients: Complication during the hospital stay(48 hours)
- Inpatients: VAS in outpatient clinic follow-up(3 months)
- Outpatients: The amount of unanticipated events(3 months)
- Inpatients: Length of hospital stay(1 month)
- Inpatients: The amount of unanticipated events(3 months)
- Inpatients: VAS before discharge(3 months)
- Inpatients/Outpatients: Compliance on ThoraxBelt after discharge(3 months)
- Outpatients: Complication during the follow-up period(6 months)
- Inpatients: IV PCA dose(48 hours)
- Inpatients/Outpatients: X-ray examination(3 months)