Clinical trial NCT05920109: EffecT of eARly analGesia With Erector Spinae Plane Block to Reduce Ventilation After Severe Chest Trauma
Official title: EffecT of eARly analGesia With Erector Spinae Plane Block to Reduce Ventilation After Severe Chest Trauma: a Randomised Control Open-label Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Severe Chest Trauma
Keywords: chest trauma
erector spinae plane block
Pain management
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: University Hospital, Clermont-Ferrand
First posted: 2023-06-27
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Blunt chest trauma is commonly associated with rib fractures and early pain management is a key goal after chest trauma. In spontaneous breathing patients, pain limits coughing efficiency and secretion clearance, thereby potentially leading to progressive atelectasis, loss of functional residual capacity (FRC) and, ultimately, respiratory distress. In patients under mechanical ventilation, pain interacts with the weaning of mechanical ventilation inducing an increase of the duration of invasive ventilation. According to recent French guidelines for chest trauma management, immediate analgesia is initially performed by intravenous multimodal analgesia followed by a thoracic epidural analgesia or a paravertebral block if the pain is not controlled within the first 12 hours. However, these blocks necessitate an experienced anaesthesiologist, are at risk of severe complications and are contraindicated in case of post-traumatic coagulopathy. All these considerations limit their indication in the trauma bay. The erector spinae plane (ESP) block is an easy to perform, ultrasound guided, regional anaesthesia for pain management after thoracic surgery. This block can be made continuously with a dedicated catheter for a continuous infusion of local anaesthetic drug with boli. The ESP block is performed by depositing the local anaesthetic in the fascial plane, deeper than the erector spinae muscle at the tip of the transverse process of the vertebra. This block is less invasive with fewer contraindications as compared to epidural analgesia or paravertebral blocks. After chest trauma, ESP block was associated with an improvement in respiratory capacity in a retrospective study. However, there is no randomised control trial assessing ESP efficacy. Our hypothesis is that early continuous ESP block in the trauma bay decreases the number of days with invasive and/or non-invasive ventilation after chest trauma.


Eligibility criteria: Inclusion Criteria:

Age \> 18 years

Blunt chest trauma with 3 or more rib fractures on Thoracic CT scan

With spontaneous breathing or under mechanical ventilation in the trauma bay

Requiring an intensive (or intermediate) care unit admission

Exclusion Criteria:

Pre-hospital cardiac arrest

Patient not expected to survive within the first 72 hours

Uncontrolled haemodynamic instability despite initial resuscitation (systolic arterial blood pressure lower than 90 mmHg at the time of catheter insertion)

Mechanical ventilation for severe traumatic brain injury (Abbreviated Injury Score, AIS, head \> 2)

Spinal cord injury at the cervical or thoracic levels

Hypovolaemia.

Hypersensitivity to ropivacaine or other amide-bound local anaesthetics

Subject in exclusion period of another interventional study

Pregnant, breastfeeding women

Primary outcomes:
measure: Assess the effect of early analgesia with continuous ESP block after chest trauma on the number of days alive and without invasive or non-invasive ventilation.
timeFrame: 30 days
Secondary outcomes:
measure: Comparison between the two groups of ESP block feasibility
timeFrame: 48 hours
measure: Comparison between the two groups of ESP block feasibility
timeFrame: 24 hours
measure: Comparison between the two groups of ESP block feasibility
timeFrame: 72 hours
measure: Comparison between the two groups of ESP block efficacy
timeFrame: 30 days
measure: Comparison between the two groups of ESP block efficacy
timeFrame: 30 days
measure: Comparison between the two groups of ESP block efficacy
timeFrame: 30 days
measure: Comparison between the two groups of ESP block efficacy on chronic pain
timeFrame: 6 months
measure: Comparison between the two groups of ESP block efficacy on neuropatic pain
timeFrame: 6 months
measure: Comparison between the two groups of ESP block safety
timeFrame: 48 hours
measure: Comparison between the two groups of ESP block safety
timeFrame: 72 hours
measure: Comparison between the two groups of ESP block safety
timeFrame: 30 days
measure: Comparison between the two groups of Morbidity and mortality
timeFrame: 30 days
measure: Comparison between the two groups of Morbidity and mortality
timeFrame: 30 days
measure: Comparison between the two groups of Morbidity and mortality
timeFrame: 30 days
measure: Comparison between the two groups of Morbidity and mortality
timeFrame: 30 days
measure: Comparison between the two groups of Morbidity and mortality
timeFrame: 6 months
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU Bordeaux - Pellegrin
city: Clamart
country: France
facility: Hôpital d'instruction des armées Percy
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
city: Clichy
country: France
facility: Hopital Beaujon - AP-HP
city: Grenoble
country: France
facility: CHU Grenoble Alpes
city: Lille
country: France
facility: CHU de Lille
city: Lyon
country: France
facility: Hôpital Edouard Herriot - HCL
city: Paris
country: France
facility: Hôpital Pitie Salpetriere - AP-HP
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou - AH-HP
city: Pierre Benite
country: France
facility: Hôpital Lyon Sud
city: Toulon
country: France
facility: Hôpital d'Instruction des Armées Sainte Anne
city: Toulouse
country: France
facility: CHU Toulouse
city: Tours
country: France
facility: CHRU Hôpitaux De Tours
city: Épagny
country: France
facility: CH Annecy Genevois
Study officials:
affiliation: Grenoble Alps University Hospital
name: BOUZAT Pierre, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Bouzat P, Raux M, David JS, Tazarourte K, Galinski M, Desmettre T, Garrigue D, Ducros L, Michelet P; Expert's group; Freysz M, Savary D, Rayeh-Pelardy F, Laplace C, Duponq R, Monnin Bares V, D'Journo XB, Boddaert G, Boutonnet M, Pierre S, Leone M, Honnart D, Biais M, Vardon F. Chest trauma: First 48hours management. Anaesth Crit Care Pain Med. 2017 Apr;36(2):135-145. doi: 10.1016/j.accpm.2017.01.003. Epub 2017 Jan 16.
citation: Blondonnet R, Begard M, Jabaudon M, Godet T, Rieu B, Audard J, Lagarde K, Futier E, Pereira B, Bouzat P, Constantin JM. Blunt Chest Trauma and Regional Anesthesia for Analgesia of Multitrauma Patients in French Intensive Care Units: A National Survey. Anesth Analg. 2021 Sep 1;133(3):723-730. doi: 10.1213/ANE.0000000000005442.
citation: Koo CH, Lee HT, Na HS, Ryu JH, Shin HJ. Efficacy of Erector Spinae Plane Block for Analgesia in Thoracic Surgery: A Systematic Review and Meta-Analysis. J Cardiothorac Vasc Anesth. 2022 May;36(5):1387-1395. doi: 10.1053/j.jvca.2021.06.029. Epub 2021 Jun 29.
citation: Chin KJ, El-Boghdadly K. Mechanisms of action of the erector spinae plane (ESP) block: a narrative review. Can J Anaesth. 2021 Mar;68(3):387-408. doi: 10.1007/s12630-020-01875-2. Epub 2021 Jan 6.
citation: White LD, Riley B, Davis K, Thang C, Mitchell A, Abi-Fares C, Basson W, Anstey C. Safety of Continuous Erector Spinae Catheters in Chest Trauma: A Retrospective Cohort Study. Anesth Analg. 2021 Nov 1;133(5):1296-1302. doi: 10.1213/ANE.0000000000005730.