Trauma AbdomenERECTRAUTHONCT05288985
Impact of Loco-regional Analgesia Following Placement of Erector Spinae Plane Catheter in Addition to Systemic Analgesia in Patients With Thoracic Trauma
A study testing Erector spinae plane catheter group in addition to Systemic Analgesia and Systemic Analgesia Only Group in people with Trauma Abdomen, run by Centre Hospitalier Departemental Vendee at 1 site in France.
Trial summary
The management of analgesia is the key issue in the management of a thoracic trauma patient to prevent respiratory complications. A multimodal approach is recommended but the question of the most suitable loco-regional analgesia technique remains. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trauma Abdomen
- What is being tested?
- Erector spinae plane catheter group in addition to Systemic Analgesia and Systemic Analgesia Only Group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 29 Jul 2022to 14 Jan 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
- Unibilateral chest trauma with fracture > 2 ribs on one side
- Admission to Intensive Care Medicine
- Non-intubated patient, able to respond to a pain scale score and perform a vital capacity
- Numerical Scale > 3 on forced inspiration despite use of systemic analgesics
- CV ≤ 80% theoretical at inclusion
Show all 10Show fewer
- Time < 24 hours from admission to the service to inclusion
- Time < 48h between trauma and inclusion
- Patient affiliated to the social security system or entitled to it
- Patient able to understand the protocol, having agreed to participate in the study and having given express oral consent
Who cannot join
- Intubated, ventilated patient
- Indication for laparotomy or thoracotomy
- Spinal cord injury
- Severe head injury
- Bilateral thoracic trauma
- Patient included in a category 1 clinical interventional study involving analgesic treatment
Show all 10Show fewer
- Patients under legal protection or deprived of liberty
- Pregnant or breastfeeding women, or women with childbearing potential without effective contraception
- Refusal to participate
- Unable to understand the protocol and its requirements and/or unable to give express oral consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Randomised, Controlled Pilot Study Evaluating the Impact of Loco-regional Analgesia Following Placement of Erector Spinae Plane Catheter in Addition to Systemic Analgesia in Patients With Thoracic Trauma
The management of analgesia is the key issue in the management of a thoracic trauma patient to prevent respiratory complications.
A multimodal approach is recommended but the question of the most suitable loco-regional analgesia technique remains. It must combine effectiveness and simplicity with the least risk to the patient. Today, epidural analgesia is the technique of choice, but it has certain disadvantages: difficulties in performing it at the thoracic level, undesirable effects, complications, and numerous contraindications.
Read more
The investigator propose to carry out a single-centre, prospective, randomised, controlled pilot study evaluating the impact of loco-regional analgesia following the placement of erector spinae plane catheter in addition to systemic analgesia in patients with unilateral thoracic trauma.
The aim is to demonstrate the effectiveness of this technique, which has fewer disadvantages than epidural analgesia. The interest of this study is thus to decrease the respiratory morbidity of thoracic trauma patients by avoiding a maximum of complications.
- Conditions
- Trauma Abdomen
- Being tested
- Erector spinae plane catheter group in addition to Systemic Analgesia, Systemic Analgesia Only Group
- Medical subject headings
- Abdominal Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector spinae plane catheter group in addition to Systemic AnalgesiaDevice
Erector spinae plane catheter is placed in the post-interventional surveillance room in the operating theatre by an anaesthetist-intensive care physician or in the MIR department by the intensive care physician in charge of the patient within 2 hours after randomisation. The local anaesthetic injected into the catheter is Ropivacaine, prescribed according to a protocol of continuous flow, bolus and refractory period. The catheter is repositioned if a secondary displacement occurs.
Systemic Analgesia Only GroupDrug
Systemic analgesia alone consists only of the 3 levels of analgesic treatment
| Study group | Role | What they receive |
|---|---|---|
| Erector spinae plane catheter group in addition to Systemic Analgesia | Experimental | Not described Receives: Device: Erector spinae plane catheter group in addition to Systemic Analgesia |
| Systemic Analgesia Only Group | Active comparator | Not described Receives: Drug: Systemic Analgesia Only Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in vital capacity between inclusion and 24 hours after inclusion.
Vital capacity is the maximum amount of air that can be breathed in and out of the lungs in one breath. It is therefore a reflection of the thoracic expansion capacity. It is expressed as a percentage of the theoretical or predicted value, which is calculated from the patient's age, height, sex and ethnic group. It is measured with the CareFusion spirometer of the MIR department, inspiration must be maximal and expiration must last at least 6 seconds in theory (3 seconds tolerated by the spirometer). 2 measurements are made and the best of the 2 is chosen.
Measured: Inclusion and 24 hours after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2022
- Study start29 Jul 2022
- Primary completion14 Jan 2026
- Study completion14 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trauma AbdomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Departemental Vendee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laureen GUILLEMIN, Principal investigator, Centre Hospitalier Départemental Vendée
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05288985
- Sponsor's protocol ID
- CHD21_0043
- Acronym
- ERECTRAUTHO
- Status last verified
- Jan 2026
- First submitted
- 11 Mar 2022
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomised, Controlled Pilot Study Evaluating the Impact of Loco-regional Analgesia Following Placement of Erector Spinae Plane Catheter in Addition to Systemic Analgesia in Patients With Thoracic Trauma
- ClinicalTrials.gov ID
- NCT05288985
- Acronym / sponsor ID
- ERECTRAUTHO / CHD21_0043
- Conditions
- Trauma Abdomen
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Centre Hospitalier Departemental VendeeUniversity, hospital or other
- Study start
- 29 Jul 2022 (actual)
- Primary completion
- 14 Jan 2026 (actual)
- Study completion
- 14 Jan 2026 (actual)
- First posted
- 21 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The management of analgesia is the key issue in the management of a thoracic trauma patient to prevent respiratory complications.
A multimodal approach is recommended but the question of the most suitable loco-regional analgesia technique remains. It must combine effectiveness and simplicity with the least risk to the patient. Today, epidural analgesia is the technique of choice, but it has certain disadvantages: difficulties in performing it at the thoracic level, undesirable effects, complications, and numerous contraindications.
The investigator propose to carry out a single-centre, prospective, randomised, controlled pilot study evaluating the impact of loco-regional analgesia following the placement of erector spinae plane catheter in addition to systemic analgesia in patients with unilateral thoracic trauma.
The aim is to demonstrate the effectiveness of this technique, which has fewer disadvantages than epidural analgesia. The interest of this study is thus to decrease the respiratory morbidity of thoracic trauma patients by avoiding a maximum of complications.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erector spinae plane catheter group in addition to Systemic Analgesia | Experimental | Device: Erector spinae plane catheter group in addition to Systemic Analgesia |
| Systemic Analgesia Only Group | Active comparator | Drug: Systemic Analgesia Only Group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥ 18 years
- Unibilateral chest trauma with fracture > 2 ribs on one side
- Admission to Intensive Care Medicine
- Non-intubated patient, able to respond to a pain scale score and perform a vital capacity
- Numerical Scale > 3 on forced inspiration despite use of systemic analgesics
Key exclusion criteria (10 listed)
- Intubated, ventilated patient
- Indication for laparotomy or thoracotomy
- Spinal cord injury
- Severe head injury
- Bilateral thoracic trauma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Erector spinae plane catheter group in addition to Systemic AnalgesiaErector spinae plane catheter is placed in the post-interventional surveillance room in the operating theatre by an anaesthetist-intensive care physician or in the MIR department by the intensive care physician in charge of the patient within 2 hours after randomisation. The local anaesthetic injected into the catheter is Ropivacaine, prescribed according to a protocol of continuous flow, bolus and refractory period. The catheter is repositioned if a secondary displacement occurs. | Device | Erector spinae plane catheter group in addition to Systemic Analgesia |
| Systemic Analgesia Only GroupSystemic analgesia alone consists only of the 3 levels of analgesic treatment | Drug | Systemic Analgesia Only Group |
Primary outcome
Change in vital capacity between inclusion and 24 hours after inclusion.
Time frame: Inclusion and 24 hours after inclusion
Vital capacity is the maximum amount of air that can be breathed in and out of the lungs in one breath. It is therefore a reflection of the thoracic expansion capacity. It is expressed as a percentage of the theoretical or predicted value, which is calculated from the patient's age, height, sex and ethnic group. It is measured with the CareFusion spirometer of the MIR department, inspiration must be maximal and expiration must last at least 6 seconds in theory (3 seconds tolerated by the spirometer). 2 measurements are made and the best of the 2 is chosen.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laureen GUILLEMIN principal investigator
Centre Hospitalier Départemental Vendée
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erector spinae plane catheter group in addition to Systemic Analgesia and Systemic Analgesia Only Group in people with Trauma Abdomen, run by Centre Hospitalier Departemental Vendee at 1 site 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 10 inclusion and 10 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 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Change in vital capacity between inclusion and 24 hours after inclusion. (time frame: Inclusion and 24 hours after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jun 2026.