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

N/ARecruitingNCT05920109

University Hospital, Grenoble400 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Interventions

ESP blockPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (14)

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

...and 4 more locations

Outcomes

Primary Outcomes

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.

Time frame: 30 days

Secondary Outcomes

Comparison between the two groups of ESP block feasibility

Number of failure of catheter placement

Time frame: 48 hours

Comparison between the two groups of ESP block feasibility

Time from admission to catheter

Time frame: 24 hours

Comparison between the two groups of ESP block feasibility

Number of attempts

Time frame: 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)

Time frame: 30 days

Comparison between the two groups of ESP block efficacy

Opioid consumption during ICU stay

Time frame: 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.

Time frame: 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

Time frame: 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

Time frame: 6 months

Comparison between the two groups of ESP block safety

Number of haematoma after ESP block puncture

Time frame: 48 hours

Comparison between the two groups of ESP block safety

Number of pneumothorax after ESP block catheter insertion

Time frame: 72 hours

Comparison between the two groups of ESP block safety

Infection of the catheter during ESP block use

Time frame: 30 days