Evaluation of the Analgesia by Serratus Plane Block During Pleural Drainage in Intensive Care Unit.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Acute pain intensity measure
研究概览
简要总结
Pleural drainage under local anesthesia is a frequent practice in resuscitation, experienced as an unpleasant and painful event for patients. Pain management is an important issue for early rehabilitation, decrease hospitalisation's cost and shortening the length of stay in intensive care unit (ICU). A new type of locoregional anesthesia called Serratus plane block described by Blanco in 2013 showed a benefit in per and postoperative analgesia in thoracic surgery and carcinologic breast surgery, allowing a decrease in morphine use and an improvement of the patient's general satisfaction. Serratus plane block is a very effective technique in chest wall analgesia, easy and safe to perform, with few complications. No studies to date have evaluated this anesthetic practice in intensive care for pleural drainage. This technique could be used outside the operating room to improve the intensive care patients, who often have heavier pathologies and greater pain, such as patients with chest trauma or patients with cardiac or respiratory disease. The investigators would like to conduct a preliminary study of superiority in the CHU Amiens intensive care unit, to study the interest of the Serratus plane block in comparison with local anesthesia on the management of acute pain during pleural drainage.
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 over 18 years old.
- •non-intubated patient with spontaneous ventilation
- •free and informed consent of the patient,
- •affiliated to a social security scheme
- •hospitalized in ICU unit including surgical ICU, cardiothoracic and respiratory ICU or cardiothoracic and respiratory continuous care unit.
- •requiring pleural drainage gas or fluid
- •conscious patient, not sedated.
排除标准
- •patient under the age of 18 years old.
- •patient refusal
- •under curatorship or deprivation of liberty
- •pregnant, parturient or breastfeeding woman
- •contraindication to Lidocaine or Ropivacaine
- •coagulation disorders
研究组 & 干预措施
AL group
patients will receive a local infiltration of 10 mL Lidocaine without epinephrine 20 mg/mL
干预措施: lidocaine treatment (Drug)
Serratus group
patients will receive ultrasound guided serratus plane block injection of 30 mL Ropivacaine 4.75 mg/mL
干预措施: serratus plane block treatment (Drug)
结局指标
主要结局
Acute pain intensity measure
时间窗: at the start of inclusion (H0)
The assessment of acute pain intensity will be done by numerical pain rating scale during plane-by-plane dissection of pleural drainage (H0). The Numeric Pain Rating Scale (NPRS) is a unidimensional measure of pain intensity in adults. The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain.\[3\] The common format is a horizontal bar or line. Similar to the VAS, the NPRS is anchored by terms describing pain severity extremes. The most commonly used is the 11-item NPRS. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").
次要结局
- Change from baseline (HO) of acute pain at rest following drainage(at 24 hours after patient inclusion)
- Change from baseline (HO) of acute pain at expiration following drainage(at 24 hours after patient inclusion)
- measure of acute pain intensity at rest(at the start of inclusion (H0))
- measure of acute pain intensity at expiration at the end of pleural drainage(at the start of inclusion (H0))