Evaluation of the Analgesia by Serratus Plane Block During Pleural Drainage in Intensive Care Unit. (SERRATUS)

Centre Hospitalier Universitaire, Amiens

Status and phase: Enrolling; Phase 3

Conditions: Lidocaine; Intensive Care Unit; Analgesia

Treatments: Drug: serratus plane block treatment; Drug: lidocaine treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT03984656

PI2018_843_0022

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

AL group

Active Comparator group

Description:

patients will receive a local infiltration of 10 mL Lidocaine without epinephrine 20 mg/mL

Treatment:

Drug: lidocaine treatment

Serratus group

Experimental group

Description:

patients will receive ultrasound guided serratus plane block injection of 30 mL Ropivacaine 4.75 mg/mL

Treatment:

Drug: serratus plane block treatment