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

Not Applicable

Recruiting

• Conditions: Severe Chest Trauma
• Interventions: Procedure: ESP block

• Registration Number: NCT05920109
• Lead Sponsor: University Hospital, Grenoble

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-04
• Study First Submitted QC: 2023-06-15
• Study First Posted: 2023-06-27
• Study Start: 2023-10-22
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-08
• Last Update Posted: 2023-12-15
• Primary Completion: 2026-12
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
experimental group	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Comparison between the two groups of ESP block safety	30 days	Infection of the catheter during ESP block use
Comparison between the two groups of ESP block efficacy	30 days	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.
Comparison between the two groups of ESP block efficacy on chronic pain	6 months	Chronic pain assessment with a verbal rating scale (VRS). 0 means no pain, 4 means worst possible pain
Comparison between the two groups of ESP block efficacy on neuropatic pain	6 months	neuropathic pain diagnostic questionnaire (DN4). this score can range from 0 to 10 and is positive if greater than or equal to 4/10
Comparison between the two groups of ESP block feasibility	72 hours	Number of attempts
Comparison between the two groups of Morbidity and mortality	6 months	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.

Trial Locations

Locations (14)

CHU Bordeaux - Pellegrin; 🇫🇷 Bordeaux, France

Hôpital d'instruction des armées Percy; 🇫🇷 Clamart, France

Hopital Beaujon - AP-HP; 🇫🇷 Clichy, France

CHU Grenoble Alpes; 🇫🇷 Grenoble, France

CHU de Lille; 🇫🇷 Lille, France

Hôpital Edouard Herriot - HCL; 🇫🇷 Lyon, France

Hôpital Pitie Salpetriere - AP-HP; 🇫🇷 Paris, France

CHU Toulouse; 🇫🇷 Toulouse, France

CHRU Hôpitaux De Tours; 🇫🇷 Tours, France

CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France

Hôpital Lyon Sud; 🇫🇷 Pierre Benite, France

Hôpital d'Instruction des Armées Sainte Anne; 🇫🇷 Toulon, France

Hôpital Européen Georges Pompidou - AH-HP; 🇫🇷 Paris, France

CH Annecy Genevois; 🇫🇷 Épagny, France