EffecT of eARly analGesia With Erector Spinae Plane Block to Reduce Ventilation After Severe Chest Trauma: a Randomised Control Open-label Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 28
- 主要终点
- Assess the effect of early analgesia with continuous ESP block after chest trauma on the number of days alive and without invasive or non-invasive ventilation.
研究概览
简要总结
Blunt chest trauma is commonly associated with rib fractures and early pain management is a key goal after chest trauma. In spontaneous breathing patients, pain limits coughing efficiency and secretion clearance, thereby potentially leading to progressive atelectasis, loss of functional residual capacity (FRC) and, ultimately, respiratory distress. In patients under mechanical ventilation, pain interacts with the weaning of mechanical ventilation inducing an increase of the duration of invasive ventilation. According to recent French guidelines for chest trauma management, immediate analgesia is initially performed by intravenous multimodal analgesia followed by a thoracic epidural analgesia or a paravertebral block if the pain is not controlled within the first 12 hours. However, these blocks necessitate an experienced anaesthesiologist, are at risk of severe complications and are contraindicated in case of post-traumatic coagulopathy. All these considerations limit their indication in the trauma bay. The erector spinae plane (ESP) block is an easy to perform, ultrasound guided, regional anaesthesia for pain management after thoracic surgery. This block can be made continuously with a dedicated catheter for a continuous infusion of local anaesthetic drug with boli. The ESP block is performed by depositing the local anaesthetic in the fascial plane, deeper than the erector spinae muscle at the tip of the transverse process of the vertebra. This block is less invasive with fewer contraindications as compared to epidural analgesia or paravertebral blocks. After chest trauma, ESP block was associated with an improvement in respiratory capacity in a retrospective study. However, there is no randomised control trial assessing ESP efficacy. Our hypothesis is that early continuous ESP block in the trauma bay decreases the number of days with invasive and/or non-invasive ventilation after chest trauma.
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
- •Age > 18 years
- •Blunt chest trauma with 3 or more rib fractures on Thoracic CT scan
- •With spontaneous breathing or under mechanical ventilation in the trauma bay
- •Requiring an intensive (or intermediate) care unit admission
排除标准
- •Pre-hospital cardiac arrest
- •Patient not expected to survive within the first 72 hours
- •Uncontrolled haemodynamic instability despite initial resuscitation (systolic arterial blood pressure lower than 90 mmHg at the time of catheter insertion)
- •Mechanical ventilation for severe traumatic brain injury (Abbreviated Injury Score, AIS, head > 2)
- •Spinal cord injury at the cervical or thoracic levels
- •Hypovolaemia.
- •Hypersensitivity to ropivacaine or other amide-bound local anaesthetics
- •Subject in exclusion period of another interventional study
- •Pregnant, breastfeeding women
结局指标
主要结局
Assess the effect of early analgesia with continuous ESP block after chest trauma on the number of days alive and without invasive or non-invasive ventilation.
时间窗: 30 days
The primary endpoint is alive and ventilator free days (VFD) within the first 30 days or hospital discharge, whichever occurred first.
次要结局
- Comparison between the two groups of ESP block efficacy on chronic pain(6 months)
- Comparison between the two groups of ESP block safety(30 days)
- Comparison between the two groups of ESP block efficacy on neuropatic pain(6 months)
- Comparison between the two groups of ESP block feasibility(72 hours)
- Comparison between the two groups of Morbidity and mortality(6 months)
- Comparison between the two groups of ESP block efficacy(30 days)