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

Study Overview
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Brief Summary
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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.

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

Conditions
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Severe Chest Trauma

Intervention / Treatment
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* Procedure: ESP block


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental group<br>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<br>* 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.<br>|
| No Intervention: control group<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison between the two groups of ESP block feasibility | Number of failure of catheter placement | 48 hours | 
| Comparison between the two groups of ESP block feasibility | Time from admission to catheter | 24 hours | 
| Comparison between the two groups of ESP block feasibility | Number of attempts | 72 hours | 
| Comparison between the two groups of ESP block efficacy | Pain at rest and during physiotherapy and coughing (Numerical Rating Scale : 0 = no pain; 10 = worst possible pain) | 30 days | 
| Comparison between the two groups of ESP block efficacy | Opioid consumption during ICU stay | 30 days | 
| Comparison between the two groups of ESP block efficacy | Spirometry parameter (maximum exhaled volume in ml) collected the first seven days of ICU stay (after extubation if mechanically ventilated). The maximal volume collected by the device is 2500 mL. | 30 days | 
| Comparison between the two groups of ESP block efficacy on chronic pain | Chronic pain assessment with a verbal rating scale (VRS). 0 means no pain, 4 means worst possible pain | 6 months | 
| Comparison between the two groups of ESP block efficacy on neuropatic pain | neuropathic pain diagnostic questionnaire (DN4). this score can range from 0 to 10 and is positive if greater than or equal to 4/10 | 6 months | 
| Comparison between the two groups of ESP block safety | Number of haematoma after ESP block puncture | 48 hours | 
| Comparison between the two groups of ESP block safety | Number of pneumothorax after ESP block catheter insertion | 72 hours | 
| Comparison between the two groups of ESP block safety | Infection of the catheter during ESP block use | 30 days | 
| Comparison between the two groups of Morbidity and mortality | Number of Hospital Acquired Pneumonia during ICU stay | 30 days | 
| Comparison between the two groups of Morbidity and mortality | Intubation rate on Day 30 | 30 days | 
| Comparison between the two groups of Morbidity and mortality | ICU-free days within the first 30 days or hospital discharge, whichever occurred first. | 30 days | 
| Comparison between the two groups of Morbidity and mortality | Mortality at Day one and at Day 30 | 30 days | 
| Comparison between the two groups of Morbidity and mortality | Quality of life at 6 months with EQ-5D-5L questionnaire. The EQ-5D-5L descriptive system comprises 5 dimensions (MOBILITY, SELF-CARE, USUAL ACTIVITIES, PAIN /DISCOMFORT and ANXIETY/DEPRESSION), each dimension has 5 response levels: no problems, slight problems, moderate problems, severe problems, unable to/extreme problems. The respondent is asked to indicate his/her health state by checking the box next to the most appropriate response level for each of the 5 dimensions. The EQ VAS records the respondent's overall current health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The EQ VAS provides a quantitative measure of the patient's perception of their overall health. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chest trauma, erector spinae plane block, Pain management