Evaluating a new pain management technique for 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
This study is testing a new pain management technique using a special catheter for people with one-sided chest injuries to see if it works better and is safer than just using regular pain medication.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Departemental Vendee Academic / other |
| Locations | 1 site (La Roche sur Yon) |
| Trial ID | NCT05288985 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of loco-regional analgesia using an erector spinae plane catheter combined with systemic analgesia in patients suffering from unilateral thoracic trauma. It aims to compare this approach to systemic analgesia alone, focusing on reducing complications associated with traditional epidural analgesia. The study is a single-centre, prospective, randomised, controlled pilot trial, enrolling patients who meet specific eligibility criteria related to their trauma and pain levels. The goal is to provide a safer and more effective pain management option for these patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with unilateral chest trauma involving more than two fractured ribs.
Not a fit: Patients who are intubated, have bilateral thoracic trauma, or require surgical intervention like laparotomy or thoracotomy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved pain management and reduced complications for patients with thoracic trauma.
How similar studies have performed: While the use of erector spinae plane catheters is gaining attention, this specific approach in the context of thoracic trauma is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
La Roche sur Yon
- Centre Hospitalier Départemental Vendée — La Roche sur Yon, France (Recruiting)
Study contacts
- Principal investigator: Laureen GUILLEMIN — Centre Hospitalier Départemental Vendée
- Study coordinator: Chloé MOREAU
- Email: chloe.moreau@ght85.fr
- Phone: 0251446327
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.