Evaluation of the Analgesia by Serratus Plane Block During Pleural Drainage in Intensive Care Unit.
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- What is being studied
- The protocol lists: lidocaine treatment, serratus plane block treatment.
- Who it may be relevant to
- Registry conditions: Analgesia, Lidocaine, Intensive Care Unit. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug lidocaine treatment
The index marks the upper edge of the lower rib of the selected intercostal space to avoid the vasculonervous bundle sitting at the lower part of the overlying rib.Non-targeted subcutaneous infiltration is performed in the drainage area with 5 to 10 mL of Lidocaine 20 mg / mL non-adrenaline, plane by plane, with regular aspiration until air or fluid confirming effusion. - Drug serratus plane block treatment
The Serratus plane block is located at the level of the 5th rib, on the midaxillary line, on the drainage side, ultrasound guided. The block is performed with a 70 mm needle in the ultrasound plane, and the needle is directed postero-inferior, after visualization of the structures from the surface to the depth: dorsal muscle * anterior serratus large muscle (serratus anterior) * intercostal muscle * 4th and 5th ribs * pleura A single injection of 30 mL of Ropivacaine 4.75 mg / mL is performed a
Primary outcome measures
- Acute pain intensity measure [Time frame: at the start of inclusion (H0)]
Secondary outcome measures (8)
- measure of acute pain intensity at rest [Time frame: at the start of inclusion (H0)]
- measure of acute pain intensity at expiration at the end of pleural drainage [Time frame: at the start of inclusion (H0)]
- Change from baseline (HO) of acute pain at rest following drainage [Time frame: at one hour after patient inclusion]
- Change from baseline (HO) of acute pain at rest following drainage [Time frame: at 6 hours after patient inclusion]
- Change from baseline (HO) of acute pain at rest following drainage [Time frame: at 24 hours after patient inclusion]
- Change from baseline (HO) of acute pain at expiration following drainage [Time frame: at 1 hour after patient inclusion]
- Change from baseline (HO) of acute pain at expiration following drainage [Time frame: at 6 hours after patient inclusion]
- Change from baseline (HO) of acute pain at expiration following drainage [Time frame: at 24 hours after patient inclusion]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
France · 1 center
- CHU Amiens — Amiens
Identifiers
NCT: NCT03984656 · PI2018_843_0022