University hospital
Montpellier, 34295, France
NCT Number: NCT04546503
Regional analgesia, based on its physiological effects and efficacy, is used for optimal perioperative pain relief. However, for acute pain in multiple trauma patients in a critical condition, it has not been prospectively studied. The use of regional anaesthesia in this group of patients extend to the management of trauma patients and of other painful procedures performed at the patient's bed. The use of RA in such patients must be analyzed in the light of associated conditions that can increase the risk of systemic toxicity and complications: coagulopathies, infection, immunosuppressive states, sedation and problems associated with mechanical ventilation. The investigators aim to assess the role of continuous peripheral nerve blocks (CPNB) in multiple trauma patients, in order to show the benefits in terms of opiates consumption decrease, sedation limitation, improvement in ventilator free days and patients outcome
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Notify Me183 month–18 year
All sexes
Interventional
Not applicable
Montpellier, 34295, France
Inclusion of multiple trauma patients with limb fractures and need for sedation and prolonged mechanical ventilation.
Patients should meet the following criterias: pressure of cerebral perfusion>60mmHg, normothermia, PaCO2 35-40 mmHg, pH> 7.20, Normal coagulation parameters, Hb> 8g / dl (without head trauma) or Hb> 10g / dl (if associated head trauma).
Randomization in two patients groups: "RA group" versus "NoRA Group
Methods:
group without locoregional anesthesia: Sedation using midazolam and sufentanil: Multi-Daily adjustment of doses every 4 hours using Behavioral Pain Scale score <4 and Ramsay Score > 4.
group with locoregional anesthesia: Sedation using midazolam and sufentanil: Multi-Daily adjustment of doses every 4 hours using Behavioral Pain Scale score <4 and Ramsay Score > 4 + peronerval block catheter from 0 to 24h after admission in intensive care unit using ropivacaine 0.2% with a continuous infusion at 1mL/10 Kg /H Follow-up up to 5 days for the 2 group. The main objective: sufentanil consumption (reported in µg / kg / d) for the same levels of Behavioral Pain Scale and Ramsay Scales values.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Aseptic placement of one or two tunnelized CPNB at the level of the nerves or plexus of the traumatized limb (s), Nervestimulation and ultrasound guidance by trained operator.
Continuous infusion of ropivacaine 0.2% at 1mL/10 Kg /H
+ General anaesthesia
General anaesthesia without regional analgesia
Time frame: up to 48 hours
assess the interest of regional anesthesia in trauma patients with fractures members. sufentanil consumption in ICU patients for sedation (µg/kg/j)
Time frame: at 24 Hours
daily consumption of sufentanil (mcg/kg/j)
Time frame: 48 Hours
daily consumption of sufentanil (mcg/kg/j)
Time frame: at 72 Hours
daily consumption of sufentanil (mcg/kg/j)
Time frame: at 96 Hours
daily consumption of sufentanil (mcg/kg/j)
Time frame: at 120 Hours
daily consumption of sufentanil (mcg/kg/j)
Time frame: at 24 Hours
daily consumption of midazolam (mg/kg/j)
Time frame: at 48 Hours
daily consumption of midazolam (mg/kg/j)
Time frame: at 72 Hours
daily consumption of midazolam (mg/kg/j)
Time frame: at 96 Hours
daily consumption of midazolam (mg/kg/j)
Time frame: at 120 Hours
daily consumption of midazolam (mg/kg/j)
Time frame: at 24 Hours
daily consumption of noradreline (mg/kg/j)
Time frame: at 48 Hours
daily consumption of noradreline (mg/kg/j)
Time frame: at 72 Hours
daily consumption of noradreline (mg/kg/j)
Time frame: at 96 Hours
daily consumption of noradreline (mg/kg/j)
Time frame: at 120 Hours
daily consumption of noradreline (mg/kg/j)
Time frame: discharge, up to end of hospitalization (Follow-up up to 5 days)
number of days between inclusion and the end of hospitalization
Time frame: discharge, up to end of hospitalization (Follow-up up to 5 days)
number of days between inclusion and the end of hospitalization
Time frame: discharge, up to end of hospitalization (Follow-up up to 5 days)
number of days between inclusion and the end of hospitalization
Time frame: From the third to the tenth day after inclusion
the rate of occurrence of pneumopathy acquired under mechanical ventilation (between 3rd and 10th day of developmen
University Hospital, Montpellier
Other
Evaluation of the Interest of Regional Locoregional Anesthesia by Perfusion Blocks in Continuous Infusion in Polytrauma Patients With Limb Fractures and Mechanical Ventilation. A Prospective Randomized Study
Acronym: ALRréa
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