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

Trauma Abdomen Clinical Trial

— ERECTRAUTHO  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05288985
• Other study ID #: CHD21_0043
• Status: Recruiting
• Phase: N/A
• Start date: July 29, 2022
• Est. completion date: August 2024

Study information

• Verified date: February 2024
• Source: Centre Hospitalier Departemental Vendee
• Contact: Chloé MOREAU
• Phone: 0251446327
• Email: chloe.moreau[@]ght85.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Injuries
• Trauma Abdomen
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
France	Centre Hospitalier Départemental Vendée	La Roche sur Yon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Departemental Vendee

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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