Reduction of Anterior Glenohumeral Dislocation in Ventral Decubitus Versus Dorsal Decubitus Under Procedural Sedation : a Prospective Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- The main objective is to evaluate the speed of the reduction of the anterior dislocation of the shoulder by the ventral decubitus technique compared to the conventional technique in dorsal decubitus.
研究概览
简要总结
The anterior glenohumeral dislocation is frequently encountered in emergency medicine. It represents about 50% of the total dislocation and affects 1 resident for 10 000 in France.
In Nord Franche-Comte Hospital, 1 to 2 patients per day present this diagnosis in the emergency department, which requires reduction by external manoeuvres.
A retrospective study shows the interest of the ventral decubitus compared to dorsal decubitus reduction in the care of patients with anterior glenohumeral dislocation. None prospective study has already demonstrate the interest of the ventral decubitus compared to the dorsal decubitus in the reduction of anterior glenohumeral dislocation.
The main objective is to evaluate the speed of the reduction of the anterior dislocation of the shoulder by the ventral decubitus technique compared to the conventional technique in dorsal decubitus.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with radiological confirmed anterior glenohumeral dislocation
- •Patient affiliated or entitled to a social security scheme
- •Oral informed consent form
排除标准
- •Glenohumeral fracture or vasculoneural lesion associated
- •Dislocation for more than 12 hours
- •Homolateral shoulder surgery antecedent
- •Contraindication to other analgesics (morphine, sedation)
- •BMI > 40
- •Patient < 18 year
- •Pregnancy or nursing woment
- •Person under guardianship or curatorship
结局指标
主要结局
The main objective is to evaluate the speed of the reduction of the anterior dislocation of the shoulder by the ventral decubitus technique compared to the conventional technique in dorsal decubitus.
时间窗: 1 day
The primary endpoint is the reduction time in minutes from inclusion of the patient after prior confirmation of the clinical and radiological diagnosis to the observed reduction.
次要结局
- Evaluation of the success rate of the ventral decubitus technique compared to the dorsal decubitus technique(1 day)
- Evaluation of the time spent in emergency department(1 day)
- Evaluation of the consumption of sedative and analgesic treatments(1 day)
- Evaluation of the pain felt before and after the intervention(1 day)