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Impact of Continuous Regional Analgesia in Severe Trauma Patients

Not Applicable
Completed
Conditions
Limb Fracture
Interventions
Procedure: Control Group
Procedure: Continuous Regional analgesia
Registration Number
NCT04546503
Lead Sponsor
University Hospital, Montpellier
Brief Summary

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

Detailed Description

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
80
Inclusion Criteria
  • Patient older than 18 years
  • Multiple trauma Patient ( with or without head trauma)
  • Patient admitted to ICU
  • Patient with limb fracture (s)
  • Patient requiring sedation and mechanical ventilation for more than 48h
  • Patient affiliated to a social security system
  • Patient whose informed consent was obtained from the family
Exclusion Criteria
  • Patient currently enrolled in another trial
  • Patient with coagulation disorders
  • Patient whose access to the puncture sites is not feasible (underlying lesions)
  • Patient with allergies to local anesthetics (LA)
  • Patient whose family did not give informed consent
  • Patient younger than 15 years and 3 months
  • Tetraplegic Patient
  • Dying patients
  • Patients with more than 3 different fracture sites

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Continuous Regional Analgesia groupControl GroupSedation using midazolam and sufentanil: Multi-Daily adjustment of doses every 4 hours using Behavioral Pain Scale score \<4 and Ramsay Score \> 4 + perinerval 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
Control GroupContinuous Regional analgesiagroup with general anesthesia and 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
Primary Outcome Measures
NameTimeMethod
sufentanil consumption in ICU patients for sedationup 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)

Secondary Outcome Measures
NameTimeMethod
ventilator free daysdischarge, up to end of hospitalization (Follow-up up to 5 days)

number of days between inclusion and the end of hospitalization

daily consumption of sufentanilat 120 Hours

daily consumption of sufentanil (mcg/kg/j)

daily consumption of midazolamat 120 Hours

daily consumption of midazolam (mg/kg/j)

daily consumption of noradrelineat 120 Hours

daily consumption of noradreline (mg/kg/j)

sedation durationdischarge, up to end of hospitalization (Follow-up up to 5 days)

number of days between inclusion and the end of hospitalization

duration of mechanical ventilationdischarge, up to end of hospitalization (Follow-up up to 5 days)

number of days between inclusion and the end of hospitalization

Mechanical ventilation complicationFrom 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

Trial Locations

Locations (1)

University hospital

🇫🇷

Montpellier, France

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