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Clinical Trials in France / NCT05920109
Recruiting Not applicable

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

NCT05920109 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2023-10-22
Last updated
2025-10-07

Condition(s) studied

Severe Chest Trauma

Investigational drug(s) / intervention(s)

ESP block

ESP block: 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.

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 outcome measure(s)

Trial sites (14)

FacilityCityRegionStatus
CHU Bordeaux - Pellegrin Bordeaux France Recruiting
Hôpital d'instruction des armées Percy Clamart France Recruiting
CHU Clermont-Ferrand Clermont-Ferrand France Recruiting
Hopital Beaujon - AP-HP Clichy France Recruiting
CH Annecy Genevois Épagny France Recruiting
CHU Grenoble Alpes Grenoble France Recruiting
CHU de Lille Lille France Recruiting
Hôpital Pitie Salpetriere - AP-HP Paris France Recruiting
Hôpital Européen Georges Pompidou - AH-HP Paris France Recruiting
Hôpital Lyon Sud Pierre-Bénite France Recruiting
Hôpital d'Instruction des Armées Sainte Anne Toulon France Recruiting
Chu Toulouse - Hopital Rangueil Toulouse France Recruiting
Chu Toulouse - Hopital Purpan Toulouse France Recruiting
CHRU Hôpitaux De Tours Tours France Recruiting

More University Hospital, Grenoble trials in France

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05920109 on ClinicalTrials.gov ↗ ← All trials in France