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

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

Sponsors

Lead Sponsor: Centre Hospitalier Universitaire, Amiens

Source Centre Hospitalier Universitaire, Amiens
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.

Overall Status Not yet recruiting
Start Date June 4, 2019
Completion Date June 4, 2021
Primary Completion Date June 4, 2021
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Acute pain intensity measure at the start of inclusion (H0)
Secondary Outcome
Measure Time Frame
measure of acute pain intensity at rest at the start of inclusion (H0)
measure of acute pain intensity at expiration at the end of pleural drainage at the start of inclusion (H0)
Change from baseline (HO) of acute pain at rest following drainage at one hour after patient inclusion
Change from baseline (HO) of acute pain at rest following drainage at 6 hours after patient inclusion
Change from baseline (HO) of acute pain at rest following drainage at 24 hours after patient inclusion
Change from baseline (HO) of acute pain at expiration following drainage at 1 hour after patient inclusion
Change from baseline (HO) of acute pain at expiration following drainage at 6 hours after patient inclusion
Change from baseline (HO) of acute pain at expiration following drainage at 24 hours after patient inclusion
Enrollment 70
Condition
Intervention

Intervention Type: Drug

Intervention Name: lidocaine treatment

Description: 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.

Arm Group Label: AL group

Intervention Type: Drug

Intervention Name: serratus plane block treatment

Description: 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.

Arm Group Label: Serratus group

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Overall Contact

Last Name: Louise Badoux, MD

Phone: (33)322087877

Email: [email protected]u-amiens.fr

Location
Facility: CHU Amiens
Location Countries

France

Verification Date

June 2019

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: AL group

Type: Active Comparator

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

Label: Serratus group

Type: Experimental

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

Acronym SERRATUS
Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov