Impact of Loco-regional Analgesia Following Placement of Erector Spinae Plane Catheter in Additio… (NCT05288985) | Clinical Trial Compass
CompletedNot Applicable
Impact of Loco-regional Analgesia Following Placement of Erector Spinae Plane Catheter in Addition to Systemic Analgesia in Patients With Thoracic Trauma
France40 participantsStarted 2022-07-29
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in vital capacity between inclusion and 24 hours after inclusion.