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

Primary Purpose

Severe Chest Trauma

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
ESP block
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe Chest Trauma focused on measuring chest trauma, erector spinae plane block, Pain management

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Bordeaux - Pellegrin
  • Hôpital d'instruction des armées Percy
  • CHU Clermont-Ferrand
  • Hopital Beaujon - AP-HP
  • CHU Grenoble Alpes
  • CHU de Lille
  • Hôpital Edouard Herriot - HCL
  • Hôpital Pitie Salpetriere - AP-HP
  • Hôpital Européen Georges Pompidou - AH-HP
  • Hôpital Lyon Sud
  • Hôpital d'Instruction des Armées Sainte Anne
  • CHU Toulouse
  • CHRU Hôpitaux De Tours
  • CH Annecy Genevois

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

experimental group

control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Comparison between the two groups of ESP block feasibility
Number of failure of catheter placement
Comparison between the two groups of ESP block feasibility
Time from admission to catheter
Comparison between the two groups of ESP block feasibility
Number of attempts
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)
Comparison between the two groups of ESP block efficacy
Opioid consumption during ICU stay
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.
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
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
Comparison between the two groups of ESP block safety
Number of haematoma after ESP block puncture
Comparison between the two groups of ESP block safety
Number of pneumothorax after ESP block catheter insertion
Comparison between the two groups of ESP block safety
Infection of the catheter during ESP block use
Comparison between the two groups of Morbidity and mortality
Number of Hospital Acquired Pneumonia during ICU stay
Comparison between the two groups of Morbidity and mortality
Intubation rate on Day 30
Comparison between the two groups of Morbidity and mortality
ICU-free days within the first 30 days or hospital discharge, whichever occurred first.
Comparison between the two groups of Morbidity and mortality
Mortality at Day one and at Day 30
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.

Full Information

First Posted
May 4, 2023
Last Updated
June 15, 2023
Sponsor
University Hospital, Grenoble
Collaborators
University Hospital, Clermont-Ferrand
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1. Study Identification

Unique Protocol Identification Number
NCT05920109
Brief Title
EffecT of eARly analGesia With Erector Spinae Plane Block to Reduce Ventilation After Severe Chest Trauma
Acronym
TARGET
Official Title
EffecT of eARly analGesia With Erector Spinae Plane Block to Reduce Ventilation After Severe Chest Trauma: a Randomised Control Open-label Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 19, 2023 (Anticipated)
Primary Completion Date
June 19, 2026 (Anticipated)
Study Completion Date
June 19, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble
Collaborators
University Hospital, Clermont-Ferrand

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Chest Trauma
Keywords
chest trauma, erector spinae plane block, Pain management

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
experimental group
Arm Type
Experimental
Arm Description
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.
Arm Title
control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
ESP block
Intervention Description
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 Outcome Measure Information:
Title
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.
Description
The primary endpoint is alive and ventilator free days (VFD) within the first 30 days or hospital discharge, whichever occurred first.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Comparison between the two groups of ESP block feasibility
Description
Number of failure of catheter placement
Time Frame
48 hours
Title
Comparison between the two groups of ESP block feasibility
Description
Time from admission to catheter
Time Frame
24 hours
Title
Comparison between the two groups of ESP block feasibility
Description
Number of attempts
Time Frame
72 hours
Title
Comparison between the two groups of ESP block efficacy
Description
Pain at rest and during physiotherapy and coughing (Numerical Rating Scale : 0 = no pain; 10 = worst possible pain)
Time Frame
30 days
Title
Comparison between the two groups of ESP block efficacy
Description
Opioid consumption during ICU stay
Time Frame
30 days
Title
Comparison between the two groups of ESP block efficacy
Description
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.
Time Frame
30 days
Title
Comparison between the two groups of ESP block efficacy on chronic pain
Description
Chronic pain assessment with a verbal rating scale (VRS). 0 means no pain, 4 means worst possible pain
Time Frame
6 months
Title
Comparison between the two groups of ESP block efficacy on neuropatic pain
Description
neuropathic pain diagnostic questionnaire (DN4). this score can range from 0 to 10 and is positive if greater than or equal to 4/10
Time Frame
6 months
Title
Comparison between the two groups of ESP block safety
Description
Number of haematoma after ESP block puncture
Time Frame
48 hours
Title
Comparison between the two groups of ESP block safety
Description
Number of pneumothorax after ESP block catheter insertion
Time Frame
72 hours
Title
Comparison between the two groups of ESP block safety
Description
Infection of the catheter during ESP block use
Time Frame
30 days
Title
Comparison between the two groups of Morbidity and mortality
Description
Number of Hospital Acquired Pneumonia during ICU stay
Time Frame
30 days
Title
Comparison between the two groups of Morbidity and mortality
Description
Intubation rate on Day 30
Time Frame
30 days
Title
Comparison between the two groups of Morbidity and mortality
Description
ICU-free days within the first 30 days or hospital discharge, whichever occurred first.
Time Frame
30 days
Title
Comparison between the two groups of Morbidity and mortality
Description
Mortality at Day one and at Day 30
Time Frame
30 days
Title
Comparison between the two groups of Morbidity and mortality
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BOUZAT Pierre, MD, PhD
Phone
0476766879
Email
pbouzat@chu-grenoble.fr
First Name & Middle Initial & Last Name or Official Title & Degree
ADOLLE Anaïs
Phone
0476766879
Email
aadolle@chu-grenoble.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
BOUZAT Pierre, MD, PhD
Organizational Affiliation
Grenoble Alps University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Bordeaux - Pellegrin
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
Hôpital d'instruction des armées Percy
City
Clamart
ZIP/Postal Code
92140
Country
France
Facility Name
CHU Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France
Facility Name
Hopital Beaujon - AP-HP
City
Clichy
ZIP/Postal Code
92118
Country
France
Facility Name
CHU Grenoble Alpes
City
Grenoble
ZIP/Postal Code
38049
Country
France
Facility Name
CHU de Lille
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
Hôpital Edouard Herriot - HCL
City
Lyon
ZIP/Postal Code
69003
Country
France
Facility Name
Hôpital Pitie Salpetriere - AP-HP
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Hôpital Européen Georges Pompidou - AH-HP
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Hôpital Lyon Sud
City
Pierre Benite
ZIP/Postal Code
69310
Country
France
Facility Name
Hôpital d'Instruction des Armées Sainte Anne
City
Toulon
ZIP/Postal Code
83000
Country
France
Facility Name
CHU Toulouse
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
CHRU Hôpitaux De Tours
City
Tours
ZIP/Postal Code
37000
Country
France
Facility Name
CH Annecy Genevois
City
Épagny
ZIP/Postal Code
74370
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19266199
Citation
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.
Results Reference
background
PubMed Identifier
32852675
Citation
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.
Results Reference
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PubMed Identifier
25204466
Citation
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.
Results Reference
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PubMed Identifier
28096063
Citation
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.
Results Reference
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PubMed Identifier
33780388
Citation
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.
Results Reference
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PubMed Identifier
34301447
Citation
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.
Results Reference
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PubMed Identifier
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Citation
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.
Results Reference
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PubMed Identifier
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Citation
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Results Reference
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EffecT of eARly analGesia With Erector Spinae Plane Block to Reduce Ventilation After Severe Chest Trauma

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