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

NCT ID: NCT03984656

Last Updated: 2023-02-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-04
• Study Completion Date: 2023-06-04

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.

Conditions

Analgesia; Lidocaine; Intensive Care Unit

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AL group

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

Group Type: ACTIVE_COMPARATOR

lidocaine treatment

Intervention Type: DRUG

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.

Serratus group

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

Group Type: EXPERIMENTAL

serratus plane block treatment

Intervention Type: DRUG

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 around the Serratus muscle.

An intravenous injection of 8 mg of Dexamethasone is added to prolong the duration of the block.

Interventions

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.

Intervention Type: 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 around the Serratus muscle.

An intravenous injection of 8 mg of Dexamethasone is added to prolong the duration of the block.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Louise Badoux, MD

Role: PRINCIPAL_INVESTIGATOR

CHU amiens

Stéphanie Malaquin, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Amiens

Osama Abou Arab, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Amiens

Locations

CHU Amiens

Amiens, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Louise Badoux, MD

Role: CONTACT

badoux.louise@chu-amiens.fr

(33)322087877

Louise Badoux, MD

Role: CONTACT

badoux.louise@chu-amiens.fr

(33)322087607

Facility Contacts

Louise Badoux, MD

Role: primary

badoux.louise@chu-amiens.fr

(33)3322087877

Other Identifiers

PI2018_843_0022

Identifier Type: -

Identifier Source: org_study_id