Clinical trial NCT03984656: Evaluation of the Analgesia by Serratus Plane Block During Pleural Drainage in Intensive Care Unit.
Official title: Evaluation of the Analgesia by Serratus Plane Block During Pleural Drainage in Intensive Care Unit.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Analgesia
Lidocaine
Intensive Care Unit
Keywords: serratus plane block
analgesia
pleural drainage
lidocaine
intensive care unit
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2019-06-13
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Acute pain intensity measure
timeFrame: at the start of inclusion (H0)
Secondary outcomes:
measure: measure of acute pain intensity at rest
timeFrame: at the start of inclusion (H0)
measure: measure of acute pain intensity at expiration at the end of pleural drainage
timeFrame: at the start of inclusion (H0)
measure: Change from baseline (HO) of acute pain at rest following drainage
timeFrame: at one hour after patient inclusion
measure: Change from baseline (HO) of acute pain at rest following drainage
timeFrame: at 6 hours after patient inclusion
measure: Change from baseline (HO) of acute pain at rest following drainage
timeFrame: at 24 hours after patient inclusion
measure: Change from baseline (HO) of acute pain at expiration following drainage
timeFrame: at 1 hour after patient inclusion
measure: Change from baseline (HO) of acute pain at expiration following drainage
timeFrame: at 6 hours after patient inclusion
measure: Change from baseline (HO) of acute pain at expiration following drainage
timeFrame: at 24 hours after patient inclusion
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
affiliation: CHU amiens
name: Louise Badoux, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Amiens
name: Stéphanie Malaquin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Amiens
name: Osama Abou Arab, MD
role: PRINCIPAL_INVESTIGATOR
References: