Back to resultsImpact of Loco-regional Analgesia Following Placement of Erector Spinae Plane Catheter in Addition to Systemic Analgesia in Patients With Thoracic Trauma (ERECTRAUTHO)
Primary Purpose
Trauma Abdomen
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Erector spinae plane catheter group in addition to Systemic Analgesia
Systemic Analgesia Only Group
Sponsored by
About this trial
This is an interventional supportive care trial for Trauma Abdomen
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 years
- Uni- or bilateral 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
- 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
Sites / Locations
- Centre Hospitalier Départemental VendéeRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Erector spinae plane catheter group in addition to Systemic Analgesia
Systemic Analgesia Only Group
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05288985
First Posted
March 11, 2022
Last Updated
December 5, 2022
Sponsor
Centre Hospitalier Departemental Vendee
1. Study Identification
Unique Protocol Identification Number
NCT05288985
Brief Title
Impact of Loco-regional Analgesia Following Placement of Erector Spinae Plane Catheter in Addition to Systemic Analgesia in Patients With Thoracic Trauma
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 29, 2022 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Departemental Vendee
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trauma Abdomen
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Erector spinae plane catheter group in addition to Systemic Analgesia
Arm Type
Experimental
Arm Title
Systemic Analgesia Only Group
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Erector spinae plane catheter group in addition to Systemic Analgesia
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Systemic Analgesia Only Group
Intervention Description
Systemic analgesia alone consists only of the 3 levels of analgesic treatment
Primary Outcome Measure Information:
Title
Change in vital capacity between inclusion and 24 hours after inclusion.
Description
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.
Time Frame
Inclusion and 24 hours after inclusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chloé MOREAU
Phone
0251446327
Ext
+33
Email
chloe.moreau@ght85.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julien HURBAULT
Organizational Affiliation
Centre Hospitalier Départemental Vendée
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Départemental Vendée
City
La Roche sur Yon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julien HURBAULT, Dr.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Impact of Loco-regional Analgesia Following Placement of Erector Spinae Plane Catheter in Addition to Systemic Analgesia in Patients With Thoracic Trauma
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