EffecT of eARly analGesia With Erector Spinae Plane Block to Reduce Ventilation After Severe Chest Trauma

NCT05920109 | Recruiting DMC

• 1 other identifier: 38RC22.0273
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 14

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.

Conditions

Severe Chest Trauma

Keywords

chest trauma; erector spinae plane block; Pain management

Outcome Measures

Primary Outcomes (1)

• 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.

  The primary endpoint is alive and ventilator free days (VFD) within the first 30 days or hospital discharge, whichever occurred first.

  30 days

Secondary Outcomes (16)

• Comparison between the two groups of ESP block feasibility

  48 hours

• Comparison between the two groups of ESP block feasibility

  24 hours

• Comparison between the two groups of ESP block feasibility

  72 hours

• Comparison between the two groups of ESP block efficacy

  30 days

• Comparison between the two groups of ESP block efficacy

  30 days

Study Arms (2)

experimental group

EXPERIMENTAL

Patients in the experimental group will have a continuous Erector Spinae Plane Block within the first 6 hours post-admission, with a continuous 1ml/h infusion of Ropivacaine (2mg/ml) associated with a 25 ml bolus every 6h.

Procedure: ESP block

control group

NO INTERVENTION

Patients in the control group will receive intravenous multimodal analgesia in the trauma bay. Thoracic epidural analgesia or continuous paravertebral block or serratus plane block will be performed within the first 12 hours post-admission if the pain is not controlled according to our national guidelines.

Interventions

ESP block PROCEDURE

Patients in the experimental group will have a continuous Erector Spinae Plane Block within the first 6 hours post-admission, with a continuous 1ml/h infusion of Ropivacaine (2mg/ml) associated with a 25 ml bolus every 6h. The catheter will be used from the trauma bay to the ICU as long as possible with a dedicated infusion pump (with a bolus mode). In case of accidental catheter removal, a second introduction of ESP block catheter is allowed within the first 24 hours. In case of continuous ESP block failure (incidence \< 5% of the total experimental group), patients will be switched to the control group.

experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Pregnant, breastfeeding women

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• University Hospital, Clermont-Ferrand: collaborator

Study Sites (14)

CHU Bordeaux - Pellegrin

Bordeaux, 33000, France

RECRUITING

Hôpital d'instruction des armées Percy

Clamart, 92140, France

RECRUITING

CHU Clermont-Ferrand

Clermont-Ferrand, 63000, France

RECRUITING

Hopital Beaujon - AP-HP

Clichy, 92118, France

RECRUITING

CH Annecy Genevois

Épagny, 74370, France

RECRUITING

CHU Grenoble Alpes

Grenoble, 38049, France

RECRUITING

CHU de Lille

Lille, 59000, France

RECRUITING

Hôpital Pitie Salpetriere - AP-HP

Paris, 75013, France

RECRUITING

Hôpital Européen Georges Pompidou - AH-HP

Paris, 75015, France

RECRUITING

Hôpital Lyon Sud

Pierre-Bénite, 69310, France

RECRUITING

Hôpital d'Instruction des Armées Sainte Anne

Toulon, 83000, France

RECRUITING

Chu Toulouse - Hopital Rangueil

Toulouse, 31059, France

RECRUITING

Chu Toulouse - Hopital Purpan

Toulouse, 69003, France

RECRUITING

CHRU Hôpitaux De Tours

Tours, 37000, France

RECRUITING

Related Publications (8)

• Veysi VT, Nikolaou VS, Paliobeis C, Efstathopoulos N, Giannoudis PV. Prevalence of chest trauma, associated injuries and mortality: a level I trauma centre experience. Int Orthop. 2009 Oct;33(5):1425-33. doi: 10.1007/s00264-009-0746-9. Epub 2009 Mar 6.

  PMID: 19266199 BACKGROUND

• Bachoumas K, Levrat A, Le Thuaut A, Rouleau S, Groyer S, Dupont H, Rooze P, Eisenmann N, Trampont T, Bohe J, Rieu B, Chakarian JC, Godard A, Frederici L, Gelinotte S, Joret A, Roques P, Painvin B, Leroy C, Benedit M, Dopeux L, Soum E, Botoc V, Fartoukh M, Hausermann MH, Kamel T, Morin J, De Varax R, Plantefeve G, Herbland A, Jabaudon M, Duburcq T, Simon C, Chabanne R, Schneider F, Ganster F, Bruel C, Laggoune AS, Bregeaud D, Souweine B, Reignier J, Lascarrou JB. Epidural analgesia in ICU chest trauma patients with fractured ribs: retrospective study of pain control and intubation requirements. Ann Intensive Care. 2020 Aug 27;10(1):116. doi: 10.1186/s13613-020-00733-0.

  PMID: 32852675 BACKGROUND

• Huber S, Biberthaler P, Delhey P, Trentzsch H, Winter H, van Griensven M, Lefering R, Huber-Wagner S; Trauma Register DGU. Predictors of poor outcomes after significant chest trauma in multiply injured patients: a retrospective analysis from the German Trauma Registry (Trauma Register DGU(R)). Scand J Trauma Resusc Emerg Med. 2014 Sep 3;22:52. doi: 10.1186/s13049-014-0052-4.

  PMID: 25204466 BACKGROUND

• 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.

  PMID: 28096063 BACKGROUND

• 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.

  PMID: 33780388 BACKGROUND

• 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.

  PMID: 34301447 BACKGROUND

• 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.

  PMID: 33403545 BACKGROUND

• 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.

  PMID: 34473654 BACKGROUND

MeSH Terms

Conditions

Thoracic Injuries; Agnosia

Condition Hierarchy (Ancestors)

Wounds and Injuries; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• BOUZAT Pierre, MD, PhD

  Grenoble Alps University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

BOUZAT Pierre, MD, PhD

CONTACT

0476766879; pbouzat@chu-grenoble.fr

ADOLLE Anaïs

CONTACT

0476766879; aadolle@chu-grenoble.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2023
• First Posted: June 27, 2023
• Study Start: October 22, 2023
• Primary Completion: January 31, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: October 7, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (14)