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

October 1, 2025 updated by: University Hospital, Grenoble

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Bordeaux, France, 33000
        • Recruiting
        • CHU Bordeaux - Pellegrin
      • Clamart, France, 92140
        • Recruiting
        • Hopital D'Instruction Des Armees Percy
      • Clermont-Ferrand, France, 63000
        • Recruiting
        • Chu Clermont-Ferrand
      • Clichy, France, 92118
        • Recruiting
        • Hopital Beaujon - AP-HP
      • Grenoble, France, 38049
        • Recruiting
        • CHU Grenoble Alpes
      • Lille, France, 59000
        • Recruiting
        • CHU de LILLE
      • Paris, France, 75013
        • Recruiting
        • Hôpital Pitie Salpetriere - AP-HP
      • Paris, France, 75015
        • Recruiting
        • Hôpital Européen Georges Pompidou - AH-HP
      • Pierre-Bénite, France, 69310
        • Recruiting
        • Hôpital Lyon Sud
      • Toulon, France, 83000
        • Recruiting
        • Hôpital d'Instruction des Armées Sainte Anne
      • Toulouse, France, 31059
        • Recruiting
        • CHU Toulouse - Hôpital Rangueil
      • Toulouse, France, 69003
        • Recruiting
        • CHU Toulouse - Hôpital Purpan
      • Tours, France, 37000
        • Recruiting
        • CHRU Hôpitaux de Tours
      • Épagny, France, 74370
        • Recruiting
        • CH Annecy Genevois

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: experimental group
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
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.
No Intervention: control group
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?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
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.
30 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Comparison between the two groups of ESP block feasibility
Time Frame: 48 hours
Number of failure of catheter placement
48 hours
Comparison between the two groups of ESP block feasibility
Time Frame: 24 hours
Time from admission to catheter
24 hours
Comparison between the two groups of ESP block feasibility
Time Frame: 72 hours
Number of attempts
72 hours
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)
30 days
Comparison between the two groups of ESP block efficacy
Time Frame: 30 days
Opioid consumption during ICU stay
30 days
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.
30 days
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
6 months
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
6 months
Comparison between the two groups of ESP block safety
Time Frame: 48 hours
Number of haematoma after ESP block puncture
48 hours
Comparison between the two groups of ESP block safety
Time Frame: 72 hours
Number of pneumothorax after ESP block catheter insertion
72 hours
Comparison between the two groups of ESP block safety
Time Frame: 30 days
Infection of the catheter during ESP block use
30 days
Comparison between the two groups of Morbidity and mortality
Time Frame: 30 days
Number of Hospital Acquired Pneumonia during ICU stay
30 days
Comparison between the two groups of Morbidity and mortality
Time Frame: 30 days
Intubation rate on Day 30
30 days
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.
30 days
Comparison between the two groups of Morbidity and mortality
Time Frame: 30 days
Mortality at Day one and at Day 30
30 days
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Grenoble

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University Hospital, Clermont-Ferrand

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: BOUZAT Pierre, MD, PhD, Grenoble Alps University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 22, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 4, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 27, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 7, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 1, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 38RC22.0273

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Severe Chest Trauma

Clinical Trials on ESP block

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings