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.

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.

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Key information

Conditions

Trauma Abdomen Abdominal Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Départemental Vendée

La Roche-sur-Yon, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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
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

Exclusion criteria

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
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

Treatment and study plan

Erector spinae plane catheter group in addition to Systemic Analgesia

Device

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 Group

Drug

Systemic analgesia alone consists only of the 3 levels of analgesic treatment

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Departemental Vendee

Other

Registry information

Official study 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

Acronym: ERECTRAUTHO

Important dates

Study start: 2022
Primary completion: 2026
Study completion: 2026
First posted: Mar 21, 2022
Registry last updated: Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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