RecruitingNot ApplicableNCT05920109

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

EffecT of eARly analGesia With Erector Spinae Plane Block to Reduce Ventilation After Severe Chest Trauma: a Randomised Control Open-label Trial.


Sponsor

University Hospital, Grenoble

Enrollment

400 participants

Start Date

Oct 22, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria9

  • 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

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Interventions

PROCEDUREESP 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.


Locations(14)

CHU Bordeaux - Pellegrin

Bordeaux, France

Hôpital d'instruction des armées Percy

Clamart, France

CHU Clermont-Ferrand

Clermont-Ferrand, France

Hopital Beaujon - AP-HP

Clichy, France

CH Annecy Genevois

Épagny, France

CHU Grenoble Alpes

Grenoble, France

CHU de Lille

Lille, France

Hôpital Pitie Salpetriere - AP-HP

Paris, France

Hôpital Européen Georges Pompidou - AH-HP

Paris, France

Hôpital Lyon Sud

Pierre-Bénite, France

Hôpital d'Instruction des Armées Sainte Anne

Toulon, France

Chu Toulouse - Hopital Rangueil

Toulouse, France

Chu Toulouse - Hopital Purpan

Toulouse, France

CHRU Hôpitaux De Tours

Tours, France

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NCT05920109