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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.

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05920109
Acronym
TARGET
Enrollment
400
Registered
2023-06-27
Start date
2023-10-22
Completion date
2027-07-31
Last updated
2025-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe Chest Trauma

Keywords

chest trauma, erector spinae plane block, Pain management

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.

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.

Sponsors

University Hospital, Clermont-Ferrand
CollaboratorOTHER
University Hospital, Grenoble
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
Comparison between the two groups of ESP block efficacy30 daysPain at rest and during physiotherapy and coughing (Numerical Rating Scale : 0 = no pain; 10 = worst possible pain)
Comparison between the two groups of ESP block efficacy on chronic pain6 monthsChronic 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 feasibility48 hoursNumber of failure of catheter placement
Comparison between the two groups of ESP block safety48 hoursNumber of haematoma after ESP block puncture
Comparison between the two groups of Morbidity and mortality30 daysNumber of Hospital Acquired Pneumonia during ICU stay
Comparison between the two groups of ESP block efficacy on neuropatic pain6 monthsneuropathic pain diagnostic questionnaire (DN4). this score can range from 0 to 10 and is positive if greater than or equal to 4/10

Countries

France

Contacts

Primary ContactBOUZAT Pierre, MD, PhD
pbouzat@chu-grenoble.fr0476766879
Backup ContactADOLLE Anaïs
aadolle@chu-grenoble.fr0476766879

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026