Prospective, Randomised, Controlled Pilot Study Evaluating the Impact of Loco-regional Analgesia Following Placement of Erector Spinae Plane Catheter in Addition to Systemic Analgesia in Patients With Thoracic Trauma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in vital capacity between inclusion and 24 hours after inclusion.
研究概览
简要总结
The management of analgesia is the key issue in the management of a thoracic trauma patient to prevent respiratory complications.
A multimodal approach is recommended but the question of the most suitable loco-regional analgesia technique remains. It must combine effectiveness and simplicity with the least risk to the patient. Today, epidural analgesia is the technique of choice, but it has certain disadvantages: difficulties in performing it at the thoracic level, undesirable effects, complications, and numerous contraindications.
The investigator propose to carry out a single-centre, prospective, randomised, controlled pilot study evaluating the impact of loco-regional analgesia following the placement of erector spinae plane catheter in addition to systemic analgesia in patients with unilateral thoracic trauma.
The aim is to demonstrate the effectiveness of this technique, which has fewer disadvantages than epidural analgesia. The interest of this study is thus to decrease the respiratory morbidity of thoracic trauma patients by avoiding a maximum of complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Unibilateral chest trauma with fracture > 2 ribs on one side
- •Admission to Intensive Care Medicine
- •Non-intubated patient, able to respond to a pain scale score and perform a vital capacity
- •Numerical Scale > 3 on forced inspiration despite use of systemic analgesics
- •CV ≤ 80% theoretical at inclusion
- •Time < 24 hours from admission to the service to inclusion
- •Time < 48h between trauma and inclusion
- •Patient affiliated to the social security system or entitled to it
- •Patient able to understand the protocol, having agreed to participate in the study and having given express oral consent
排除标准
- •Intubated, ventilated patient
- •Indication for laparotomy or thoracotomy
- •Spinal cord injury
- •Severe head injury
- •Bilateral thoracic trauma
- •Patient included in a category 1 clinical interventional study involving analgesic treatment
- •Patients under legal protection or deprived of liberty
- •Pregnant or breastfeeding women, or women with childbearing potential without effective contraception
- •Refusal to participate
- •Unable to understand the protocol and its requirements and/or unable to give express oral consent
研究组 & 干预措施
Erector spinae plane catheter group in addition to Systemic Analgesia
干预措施: Erector spinae plane catheter group in addition to Systemic Analgesia (Device)
Systemic Analgesia Only Group
干预措施: Systemic Analgesia Only Group (Drug)
结局指标
主要结局
Change in vital capacity between inclusion and 24 hours after inclusion.
时间窗: Inclusion and 24 hours after inclusion
Vital capacity is the maximum amount of air that can be breathed in and out of the lungs in one breath. It is therefore a reflection of the thoracic expansion capacity. It is expressed as a percentage of the theoretical or predicted value, which is calculated from the patient's age, height, sex and ethnic group. It is measured with the CareFusion spirometer of the MIR department, inspiration must be maximal and expiration must last at least 6 seconds in theory (3 seconds tolerated by the spirometer). 2 measurements are made and the best of the 2 is chosen.
次要结局
未报告次要终点