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

NCT ID: NCT05288985

Last Updated: 2026-01-12

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-29
• Study Completion Date: 2026-01-14

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Erector spinae plane catheter group in addition to Systemic Analgesia

Group Type: EXPERIMENTAL

Erector spinae plane catheter group in addition to Systemic Analgesia

Intervention Type: 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

Group Type: ACTIVE_COMPARATOR

Systemic Analgesia Only Group

Intervention Type: DRUG

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

Interventions

Erector spinae plane catheter group in addition to Systemic Analgesia

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.

Intervention Type: DEVICE

Systemic Analgesia Only Group

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Departemental Vendee

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laureen GUILLEMIN

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Départemental Vendée

Locations

Centre Hospitalier Départemental Vendée

La Roche-sur-Yon, , France

Countries

France

Other Identifiers

CHD21_0043

Identifier Type: -

Identifier Source: org_study_id