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Severe Chest TraumaTARGETNCT05920109

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

A study testing ESP block in people with Severe Chest Trauma, run by University Hospital, Grenoble at 14 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Severe Chest Trauma
What is being tested?
ESP block
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
14 sitesFrance
Study dates
22 Oct 2023to 15 Sep 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 9Show fewer
  • Hypersensitivity to ropivacaine or other amide-bound local anaesthetics
  • Subject in exclusion period of another interventional study
  • Pregnant, breastfeeding women

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

France14 sites
  • CHU Bordeaux - Pellegrin

    Bordeaux, 33000

  • Hôpital d'instruction des armées Percy

    Clamart, 92140

  • CHU Clermont-Ferrand

    Clermont-Ferrand, 63000

  • Hopital Beaujon - AP-HP

    Clichy, 92118

  • CH Annecy Genevois

    Épagny, 74370

  • CHU Grenoble Alpes

    Grenoble, 38049

  • CHU de Lille

    Lille, 59000

  • Hôpital Pitie Salpetriere - AP-HP

    Paris, 75013

  • Hôpital Européen Georges Pompidou - AH-HP

    Paris, 75015

  • Hôpital Lyon Sud

    Pierre-Bénite, 69310

  • Hôpital d'Instruction des Armées Sainte Anne

    Toulon, 83000

  • Chu Toulouse - Hopital Rangueil

    Toulouse, 31059

  • Chu Toulouse - Hopital Purpan

    Toulouse, 69003

  • CHRU Hôpitaux De Tours

    Tours, 37000

Other trials in France

About this study

Official title: 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.

Being tested
ESP block
Keywords
chest trauma, erector spinae plane block, Pain management
Medical subject headings
Thoracic Injuries, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ESP blockProcedure or surgery

    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.

Study groups in NCT05920109
Study groupRoleWhat they receive
experimental groupExperimentalPatients 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.
Receives: Procedure: ESP block
control groupNo interventionPatients 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 being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

    Measured: 30 days

Secondary outcomes (16)
  1. Comparison between the two groups of ESP block feasibility

    Number of failure of catheter placement

    Measured: 48 hours

  2. Comparison between the two groups of ESP block feasibility

    Time from admission to catheter

    Measured: 24 hours

  3. Comparison between the two groups of ESP block feasibility

    Number of attempts

    Measured: 72 hours

  4. 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)

    Measured: 30 days

  5. Comparison between the two groups of ESP block efficacy

    Opioid consumption during ICU stay

    Measured: 30 days

  6. 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.

    Measured: 30 days

  7. 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

    Measured: 6 months

  8. 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

    Measured: 6 months

  9. Comparison between the two groups of ESP block safety

    Number of haematoma after ESP block puncture

    Measured: 48 hours

  10. Comparison between the two groups of ESP block safety

    Number of pneumothorax after ESP block catheter insertion

    Measured: 72 hours

  11. Comparison between the two groups of ESP block safety

    Infection of the catheter during ESP block use

    Measured: 30 days

  12. Comparison between the two groups of Morbidity and mortality

    Number of Hospital Acquired Pneumonia during ICU stay

    Measured: 30 days

  13. Comparison between the two groups of Morbidity and mortality

    Intubation rate on Day 30

    Measured: 30 days

  14. Comparison between the two groups of Morbidity and mortality

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

    Measured: 30 days

  15. Comparison between the two groups of Morbidity and mortality

    Mortality at Day one and at Day 30

    Measured: 30 days

  16. Comparison between the two groups of Morbidity and mortality

    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.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2023
  2. Study start22 Oct 2023
  3. Primary completion3 Mar 2026
  4. Study completion15 Sep 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
400 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05920109
Sponsor's protocol ID
38RC22.0273
Acronym
TARGET
Status last verified
Oct 2026
First submitted
4 May 2023
Last updated
20 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Veysi VT, Nikolaou VS, Paliobeis C, Efstathopoulos N, Giannoudis PV. Prevalence of chest trauma, associated injuries and mortality: a level I trauma centre experience. Int Orthop. 2009 Oct;33(5):1425-33. doi: 10.1007/s00264-009-0746-9. Epub 2009 Mar 6.

    PubMed 19266199
  • Bachoumas K, Levrat A, Le Thuaut A, Rouleau S, Groyer S, Dupont H, Rooze P, Eisenmann N, Trampont T, Bohe J, Rieu B, Chakarian JC, Godard A, Frederici L, Gelinotte S, Joret A, Roques P, Painvin B, Leroy C, Benedit M, Dopeux L, Soum E, Botoc V, Fartoukh M, Hausermann MH, Kamel T, Morin J, De Varax R, Plantefeve G, Herbland A, Jabaudon M, Duburcq T, Simon C, Chabanne R, Schneider F, Ganster F, Bruel C, Laggoune AS, Bregeaud D, Souweine B, Reignier J, Lascarrou JB. Epidural analgesia in ICU chest trauma patients with fractured ribs: retrospective study of pain control and intubation requirements. Ann Intensive Care. 2020 Aug 27;10(1):116. doi: 10.1186/s13613-020-00733-0.

    PubMed 32852675
  • Huber S, Biberthaler P, Delhey P, Trentzsch H, Winter H, van Griensven M, Lefering R, Huber-Wagner S; Trauma Register DGU. Predictors of poor outcomes after significant chest trauma in multiply injured patients: a retrospective analysis from the German Trauma Registry (Trauma Register DGU(R)). Scand J Trauma Resusc Emerg Med. 2014 Sep 3;22:52. doi: 10.1186/s13049-014-0052-4.

    PubMed 25204466
  • Bouzat P, Raux M, David JS, Tazarourte K, Galinski M, Desmettre T, Garrigue D, Ducros L, Michelet P; Expert's group; Freysz M, Savary D, Rayeh-Pelardy F, Laplace C, Duponq R, Monnin Bares V, D'Journo XB, Boddaert G, Boutonnet M, Pierre S, Leone M, Honnart D, Biais M, Vardon F. Chest trauma: First 48hours management. Anaesth Crit Care Pain Med. 2017 Apr;36(2):135-145. doi: 10.1016/j.accpm.2017.01.003. Epub 2017 Jan 16.

    PubMed 28096063
  • Blondonnet R, Begard M, Jabaudon M, Godet T, Rieu B, Audard J, Lagarde K, Futier E, Pereira B, Bouzat P, Constantin JM. Blunt Chest Trauma and Regional Anesthesia for Analgesia of Multitrauma Patients in French Intensive Care Units: A National Survey. Anesth Analg. 2021 Sep 1;133(3):723-730. doi: 10.1213/ANE.0000000000005442.

    PubMed 33780388
  • Koo CH, Lee HT, Na HS, Ryu JH, Shin HJ. Efficacy of Erector Spinae Plane Block for Analgesia in Thoracic Surgery: A Systematic Review and Meta-Analysis. J Cardiothorac Vasc Anesth. 2022 May;36(5):1387-1395. doi: 10.1053/j.jvca.2021.06.029. Epub 2021 Jun 29.

    PubMed 34301447
  • Chin KJ, El-Boghdadly K. Mechanisms of action of the erector spinae plane (ESP) block: a narrative review. Can J Anaesth. 2021 Mar;68(3):387-408. doi: 10.1007/s12630-020-01875-2. Epub 2021 Jan 6.

    PubMed 33403545
  • White LD, Riley B, Davis K, Thang C, Mitchell A, Abi-Fares C, Basson W, Anstey C. Safety of Continuous Erector Spinae Catheters in Chest Trauma: A Retrospective Cohort Study. Anesth Analg. 2021 Nov 1;133(5):1296-1302. doi: 10.1213/ANE.0000000000005730.

    PubMed 34473654
  • Bouzat P, Adolle A, Gauss T, Perreira B, Constantin JM. Effect of early analgesia with erector spinae plane block to reduce ventilation after severe chest trauma: the multicentre randomised controlled TARGET study protocol. BMJ Open. 2026 Jul 31;16(7):e117195. doi: 10.1136/bmjopen-2026-117195.

    PubMed 42538106

Questions about this trial

What is this clinical trial studying?

A study testing ESP block in people with Severe Chest Trauma, run by University Hospital, Grenoble at 14 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05920109, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.

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