2024-515722-83-00招募中3 期
SERRATUS : Evaluation of the Analgesia by Serratus Plane Block During Pleural Drainage in Intensive Care Unit.
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Intensity of acute pain during pleural drainage (H0) by numerical scale (EN).
研究概览
简要总结
Evaluate the impact of serratus block compared to local anesthesia, on the management of acute pain during the performance of pleural drainage in multipurpose intensive care unit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Etude pilote, prospective, contrôlée, randomisée, comparative, en simple aveugle
- 盲法
- Single (Subject)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Patient aged 18 or over, not intubated, spontaneously ventilating.
- •Free and informed consent signed.
- •Affiliate to a social security scheme.
- •Hospitalized in multipurpose intensive care unit including surgical resuscitation, cardiothoracic and respiratory resuscitation or continuing cardiothoracic and respiratory care services.
- •Requiring gas or fluid pleural drainage.
排除标准
- •Patient didn't agree to participate in the trial.
- •Patient under guardianship or curatorship or deprived of liberty.
- •Pregnant, parturient or breastfeeding woman.
- •Allergy and contraindication to Lidocaine or Ropivacaine.
- •Coagulation disorders.
结局指标
主要结局
Intensity of acute pain during pleural drainage (H0) by numerical scale (EN).
Intensity of acute pain during pleural drainage (H0) by numerical scale (EN).
次要结局
- Use of tracheal intubation.
- Intensity of acute pain by EN at rest and during exercise (forced inspiration) at the end of pleural drainage (H0).
- Intensity of acute pain from EN at rest and during exercise (cough and forced inspiration) after drainage over the first 24 hours (H0, H1, H6, H24).
- Clinical tolerance at the end of drainage (H0): MAP HR, FR, SpO2.
- Lung capacity in milliliters measured by the Voldyne (maximum inspired volume) H1, H6, H24.
- Respiratory complications: - atelectasis = auscultation + radiography or ultrasound - nosocomial pneumonia = 3 clinicoradiological criteria compatible with radiological infiltrate + hyperthermia (>38 or <36°C) or leukocytes (>12000 or <4000 GB/mm3) + purulent aspirations or suggestive auscultation or hypoxemia.
- Early rehabilitation: time to first getting up, physiotherapy.
- Duration of drainage.
- Duration of stay in intensive care.
- Duration of installation of anesthesia.
研究者
Stéphanie MALAQUIN
Scientific
Centre Hospitalier Universitaire Amiens Picardie
研究点 (1)
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