Clinical trial NCT05288985: Impact of Loco-regional Analgesia Following Placement of Erector Spinae Plane Catheter in Addition to Systemic Analgesia in Patients With Thoracic Trauma
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Trauma Abdomen
Lead sponsor: Centre Hospitalier Departemental Vendee
Sponsor class: OTHER
First posted: 2022-03-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Change in vital capacity between inclusion and 24 hours after inclusion.
timeFrame: Inclusion and 24 hours after inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: La Roche sur Yon
country: France
facility: Centre Hospitalier Départemental Vendée
Study officials:
affiliation: Centre Hospitalier Départemental Vendée
name: Laureen GUILLEMIN
role: PRINCIPAL_INVESTIGATOR
References: