- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03984656
Evaluation of the Analgesia by Serratus Plane Block During Pleural Drainage in Intensive Care Unit. (SERRATUS)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Louise Badoux, MD
- Phone Number: (33)322087877
- Email: badoux.louise@chu-amiens.fr
Study Contact Backup
- Name: Louise Badoux, MD
- Phone Number: (33)322087607
- Email: badoux.louise@chu-amiens.fr
Study Locations
-
-
-
Amiens, France, 80000
- Recruiting
- CHU Amiens
-
Contact:
- Louise Badoux, MD
- Phone Number: (33)3322087877
- Email: badoux.louise@chu-amiens.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: AL group
patients will receive a local infiltration of 10 mL Lidocaine without epinephrine 20 mg/mL
|
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.
|
EXPERIMENTAL: Serratus group
patients will receive ultrasound guided serratus plane block injection of 30 mL Ropivacaine 4.75 mg/mL
|
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
An intravenous injection of 8 mg of Dexamethasone is added to prolong the duration of the block. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acute pain intensity measure
Time Frame: at the start of inclusion (H0)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
measure of acute pain intensity at rest
Time Frame: at the start of inclusion (H0)
|
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)
|
measure of acute pain intensity at expiration at the end of pleural drainage
Time Frame: at the start of inclusion (H0)
|
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)
|
Change from baseline (HO) of acute pain at rest following drainage
Time Frame: at one hour after patient inclusion
|
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
|
Change from baseline (HO) of acute pain at rest following drainage
Time Frame: at 6 hours after patient inclusion
|
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
|
Change from baseline (HO) of acute pain at rest following drainage
Time Frame: at 24 hours after patient inclusion
|
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
|
Change from baseline (HO) of acute pain at expiration following drainage
Time Frame: at 1 hour after patient inclusion
|
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
|
Change from baseline (HO) of acute pain at expiration following drainage
Time Frame: at 6 hours after patient inclusion
|
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
|
Change from baseline (HO) of acute pain at expiration following drainage
Time Frame: at 24 hours after patient inclusion
|
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
|
Collaborators and Investigators
Investigators
- Principal Investigator: Louise Badoux, MD, CHU Amiens
- Principal Investigator: Stéphanie Malaquin, MD, CHU Amiens
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Perceptual Disorders
- Agnosia
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Membrane Transport Modulators
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Lidocaine
Other Study ID Numbers
- PI2018_843_0022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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