NCT05288985

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Centre Hospitalier Departemental Vendee · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	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.
DRUG	Systemic Analgesia Only Group	Systemic analgesia alone consists only of the 3 levels of analgesic treatment

Timeline

• Start date: 2022-07-29
• Primary completion: 2026-01-14
• Completion: 2026-01-14
• First posted: 2022-03-21
• Last updated: 2026-01-12

Locations

1 site across 1 country: France