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

Analgesia Clinical Trial

— SERRATUS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03984656
• Other study ID #: PI2018_843_0022
• Status: Recruiting
• Phase: Phase 3
• Start date: June 4, 2019
• Est. completion date: June 4, 2023

Study information

• Verified date: February 2023
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: Louise Badoux, MD
• Phone: (33)322087877
• Email: badoux.louise[@]chu-amiens.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: June 4, 2023
• Est. primary completion date: June 4, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Analgesia
• Intensive Care Unit
• Lidocaine

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	CHU Amiens	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute pain intensity measure	The assessment of acute pain intensity will be done by numerical pain rating scale during plane-by-plane dissection of pleural drainage (H0). The Numeric Pain Rating Scale (NPRS) is a unidimensional measure of pain intensity in adults. The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain.[3] The common format is a horizontal bar or line. Similar to the VAS, the NPRS is anchored by terms describing pain severity extremes. The most commonly used is the 11-item NPRS. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").	at the start of inclusion (H0)
Secondary	measure of acute pain intensity at rest	The assessment of acute pain intensity will be done by numerical pain rating scale during plane-by-plane dissection of pleural drainage (H0). The Numeric Pain Rating Scale (NPRS) is a unidimensional measure of pain intensity in adults. The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain.[3] The common format is a horizontal bar or line. Similar to the VAS, the NPRS is anchored by terms describing pain severity extremes. The most commonly used is the 11-item NPRS. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").	at the start of inclusion (H0)
Secondary	measure of acute pain intensity at expiration at the end of pleural drainage	The assessment of acute pain intensity will be done by numerical pain rating scale during plane-by-plane dissection of pleural drainage (H0). The Numeric Pain Rating Scale (NPRS) is a unidimensional measure of pain intensity in adults. The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain.[3] The common format is a horizontal bar or line. Similar to the VAS, the NPRS is anchored by terms describing pain severity extremes. The most commonly used is the 11-item NPRS. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").	at the start of inclusion (H0)
Secondary	Change from baseline (HO) of acute pain at rest following drainage	The assessment of acute pain intensity will be done by numerical pain rating scale during plane-by-plane dissection of pleural drainage (H0). The Numeric Pain Rating Scale (NPRS) is a unidimensional measure of pain intensity in adults. The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain.[3] The common format is a horizontal bar or line. Similar to the VAS, the NPRS is anchored by terms describing pain severity extremes. The most commonly used is the 11-item NPRS. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").	at one hour after patient inclusion
Secondary	Change from baseline (HO) of acute pain at rest following drainage	The assessment of acute pain intensity will be done by numerical pain rating scale during plane-by-plane dissection of pleural drainage (H0). The Numeric Pain Rating Scale (NPRS) is a unidimensional measure of pain intensity in adults. The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain.[3] The common format is a horizontal bar or line. Similar to the VAS, the NPRS is anchored by terms describing pain severity extremes. The most commonly used is the 11-item NPRS. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").	at 6 hours after patient inclusion
Secondary	Change from baseline (HO) of acute pain at rest following drainage	The assessment of acute pain intensity will be done by numerical pain rating scale during plane-by-plane dissection of pleural drainage (H0). The Numeric Pain Rating Scale (NPRS) is a unidimensional measure of pain intensity in adults. The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain.[3] The common format is a horizontal bar or line. Similar to the VAS, the NPRS is anchored by terms describing pain severity extremes. The most commonly used is the 11-item NPRS. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").	at 24 hours after patient inclusion
Secondary	Change from baseline (HO) of acute pain at expiration following drainage	The assessment of acute pain intensity will be done by numerical pain rating scale during plane-by-plane dissection of pleural drainage (H0). The Numeric Pain Rating Scale (NPRS) is a unidimensional measure of pain intensity in adults. The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain.[3] The common format is a horizontal bar or line. Similar to the VAS, the NPRS is anchored by terms describing pain severity extremes. The most commonly used is the 11-item NPRS. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").	at 1 hour after patient inclusion
Secondary	Change from baseline (HO) of acute pain at expiration following drainage	The assessment of acute pain intensity will be done by numerical pain rating scale during plane-by-plane dissection of pleural drainage (H0). The Numeric Pain Rating Scale (NPRS) is a unidimensional measure of pain intensity in adults. The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain.[3] The common format is a horizontal bar or line. Similar to the VAS, the NPRS is anchored by terms describing pain severity extremes. The most commonly used is the 11-item NPRS. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").	at 6 hours after patient inclusion
Secondary	Change from baseline (HO) of acute pain at expiration following drainage	The assessment of acute pain intensity will be done by numerical pain rating scale during plane-by-plane dissection of pleural drainage (H0). The Numeric Pain Rating Scale (NPRS) is a unidimensional measure of pain intensity in adults. The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain.[3] The common format is a horizontal bar or line. Similar to the VAS, the NPRS is anchored by terms describing pain severity extremes. The most commonly used is the 11-item NPRS. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").	at 24 hours after patient inclusion