Clinical trial
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
Name
CHD21_0043
Description
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.
Trial arms
Trial start
2022-07-29
Estimated PCD
2026-07-01
Trial end
2026-07-01
Status
Recruiting
Treatment
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.
Arms:
Erector spinae plane catheter group in addition to Systemic Analgesia
Systemic Analgesia Only Group
Systemic analgesia alone consists only of the 3 levels of analgesic treatment
Arms:
Systemic Analgesia Only Group
Size
40
Primary endpoint
Change in vital capacity between inclusion and 24 hours after inclusion.
Inclusion and 24 hours after inclusion
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}
Updated at
2024-05-29
1 organization
1 product
1 indication
Organization
Centre Hospitalier Departemental VendeeIndication
Abdominal trauma