Evaluation of the Interest of Regional Locoregional Anesthesia by Perfusion Blocks in Continuous Infusion in Polytrauma Patients With Limb Fractures and Mechanical Ventilation. A Prospective Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- sufentanil consumption in ICU patients for sedation
研究概览
简要总结
Regional analgesia, based on its physiological effects and efficacy, is used for optimal perioperative pain relief. However, for acute pain in multiple trauma patients in a critical condition, it has not been prospectively studied. The use of regional anaesthesia in this group of patients extend to the management of trauma patients and of other painful procedures performed at the patient's bed. The use of RA in such patients must be analyzed in the light of associated conditions that can increase the risk of systemic toxicity and complications: coagulopathies, infection, immunosuppressive states, sedation and problems associated with mechanical ventilation. The investigators aim to assess the role of continuous peripheral nerve blocks (CPNB) in multiple trauma patients, in order to show the benefits in terms of opiates consumption decrease, sedation limitation, improvement in ventilator free days and patients outcome
详细描述
Inclusion of multiple trauma patients with limb fractures and need for sedation and prolonged mechanical ventilation.
Patients should meet the following criterias: pressure of cerebral perfusion>60mmHg, normothermia, PaCO2 35-40 mmHg, pH> 7.20, Normal coagulation parameters, Hb> 8g / dl (without head trauma) or Hb> 10g / dl (if associated head trauma).
Randomization in two patients groups: "RA group" versus "NoRA Group
Methods:
group without locoregional anesthesia: Sedation using midazolam and sufentanil: Multi-Daily adjustment of doses every 4 hours using Behavioral Pain Scale score <4 and Ramsay Score > 4.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Investigator)
盲法说明
The investigator responsible for assessing sedation and adjusting dosages hypnotic and morphinic (according to objectives) will not be aware of the result of the randomization.
入排标准
- 年龄范围
- 183 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient older than 18 years
- •Multiple trauma Patient ( with or without head trauma)
- •Patient admitted to ICU
- •Patient with limb fracture (s)
- •Patient requiring sedation and mechanical ventilation for more than 48h
- •Patient affiliated to a social security system
- •Patient whose informed consent was obtained from the family
排除标准
- •Patient currently enrolled in another trial
- •Patient with coagulation disorders
- •Patient whose access to the puncture sites is not feasible (underlying lesions)
- •Patient with allergies to local anesthetics (LA)
- •Patient whose family did not give informed consent
- •Patient younger than 15 years and 3 months
- •Tetraplegic Patient
- •Dying patients
- •Patients with more than 3 different fracture sites
结局指标
主要结局
sufentanil consumption in ICU patients for sedation
时间窗: up to 48 hours
assess the interest of regional anesthesia in trauma patients with fractures members. sufentanil consumption in ICU patients for sedation (µg/kg/j)
次要结局
- ventilator free days(discharge, up to end of hospitalization (Follow-up up to 5 days))
- daily consumption of sufentanil(at 120 Hours)
- daily consumption of midazolam(at 120 Hours)
- daily consumption of noradreline(at 120 Hours)
- sedation duration(discharge, up to end of hospitalization (Follow-up up to 5 days))
- duration of mechanical ventilation(discharge, up to end of hospitalization (Follow-up up to 5 days))
- Mechanical ventilation complication(From the third to the tenth day after inclusion)