Impact of Loco-regional Analgesia Following Placement of Erector Spinae Plane Catheter in Addition to Systemic Analgesia in Patients With Thoracic Trauma

NCT05288985 | Active Not Recruiting

• 1 other identifier: CHD21_0043
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Trauma Abdomen

Outcome Measures

Primary Outcomes (1)

• 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.

  Inclusion and 24 hours after inclusion

Study Arms (2)

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

Interventions

Systemic Analgesia Only Group DRUG

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

Systemic Analgesia Only Group

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.

Erector spinae plane catheter group in addition to Systemic Analgesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Departemental Vendee: lead

Study Sites (1)

Centre Hospitalier Départemental Vendée

La Roche-sur-Yon, France

Location

MeSH Terms

Conditions

Abdominal Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Laureen GUILLEMIN

  Centre Hospitalier Départemental Vendée

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2022
• First Posted: March 21, 2022
• Study Start: July 29, 2022
• Primary Completion: January 14, 2026
• Study Completion: January 14, 2026
• Last Updated: January 12, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)