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NCT Number: NCT05920109

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Bordeaux - Pellegrin, Bordeaux, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ESP block

Procedure

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.

Primary outcomes

  1. 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.

    Time frame: 30 days

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

Secondary outcomes

  1. Comparison between the two groups of ESP block feasibility

    Time frame: 48 hours

    Number of failure of catheter placement

  2. Comparison between the two groups of ESP block feasibility

    Time frame: 24 hours

    Time from admission to catheter

  3. Comparison between the two groups of ESP block feasibility

    Time frame: 72 hours

    Number of attempts

  4. Comparison between the two groups of ESP block efficacy

    Time frame: 30 days

    Pain at rest and during physiotherapy and coughing (Numerical Rating Scale : 0 = no pain; 10 = worst possible pain)

  5. Comparison between the two groups of ESP block efficacy

    Time frame: 30 days

    Opioid consumption during ICU stay

  6. Comparison between the two groups of ESP block efficacy

    Time frame: 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.

  7. Comparison between the two groups of ESP block efficacy on chronic pain

    Time frame: 6 months

    Chronic pain assessment with a verbal rating scale (VRS). 0 means no pain, 4 means worst possible pain

  8. Comparison between the two groups of ESP block efficacy on neuropatic pain

    Time frame: 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

  9. Comparison between the two groups of ESP block safety

    Time frame: 48 hours

    Number of haematoma after ESP block puncture

  10. Comparison between the two groups of ESP block safety

    Time frame: 72 hours

    Number of pneumothorax after ESP block catheter insertion

  11. Comparison between the two groups of ESP block safety

    Time frame: 30 days

    Infection of the catheter during ESP block use

  12. Comparison between the two groups of Morbidity and mortality

    Time frame: 30 days

    Number of Hospital Acquired Pneumonia during ICU stay

  13. Comparison between the two groups of Morbidity and mortality

    Time frame: 30 days

    Intubation rate on Day 30

  14. Comparison between the two groups of Morbidity and mortality

    Time frame: 30 days

    ICU-free days within the first 30 days or hospital discharge, whichever occurred first.

  15. Comparison between the two groups of Morbidity and mortality

    Time frame: 30 days

    Mortality at Day one and at Day 30

  16. Comparison between the two groups of Morbidity and mortality

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

ADOLLE Anaïs

CONTACT

[email protected]

0476766879

BOUZAT Pierre, MD, PhD

CONTACT

[email protected]

0476766879

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Collaborators

  • University Hospital, Clermont-Ferrand

Registry information

Official study title

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

Acronym: TARGET

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Jun 27, 2023
Registry last updated
Oct 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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