Impact of Continuous Regional Analgesia in Severe Trauma Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Limb Fracture

Intervention / Treatment
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* Procedure: Continuous Regional analgesia
* Procedure: Control Group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 183 Months
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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 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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Continuous Regional Analgesia group<br>Sedation 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 | Procedure: Control Group<br>* General anaesthesia without regional analgesia<br>|
| Experimental: Control Group<br>group 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 | Procedure: Continuous Regional analgesia<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sufentanil consumption in ICU patients for sedation | assess the interest of regional anesthesia in trauma patients with fractures members. sufentanil consumption in ICU patients for sedation (µg/kg/j) | up to 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| daily consumption of sufentanil | daily consumption of sufentanil (mcg/kg/j) | at 24 Hours | 
| daily consumption of sufentanil | daily consumption of sufentanil (mcg/kg/j) | 48 Hours | 
| daily consumption of sufentanil | daily consumption of sufentanil (mcg/kg/j) | at 72 Hours | 
| daily consumption of sufentanil | daily consumption of sufentanil (mcg/kg/j) | at 96 Hours | 
| daily consumption of sufentanil | daily consumption of sufentanil (mcg/kg/j) | at 120 Hours | 
| daily consumption of midazolam | daily consumption of midazolam (mg/kg/j) | at 24 Hours | 
| daily consumption of midazolam | daily consumption of midazolam (mg/kg/j) | at 48 Hours | 
| daily consumption of midazolam | daily consumption of midazolam (mg/kg/j) | at 72 Hours | 
| daily consumption of midazolam | daily consumption of midazolam (mg/kg/j) | at 96 Hours | 
| daily consumption of midazolam | daily consumption of midazolam (mg/kg/j) | at 120 Hours | 
| daily consumption of noradreline | daily consumption of noradreline (mg/kg/j) | at 24 Hours | 
| daily consumption of noradreline | daily consumption of noradreline (mg/kg/j) | at 48 Hours | 
| daily consumption of noradreline | daily consumption of noradreline (mg/kg/j) | at 72 Hours | 
| daily consumption of noradreline | daily consumption of noradreline (mg/kg/j) | at 96 Hours | 
| daily consumption of noradreline | daily consumption of noradreline (mg/kg/j) | at 120 Hours | 
| sedation duration | number of days between inclusion and the end of hospitalization | discharge, up to end of hospitalization (Follow-up up to 5 days) | 
| ventilator free days | number of days between inclusion and the end of hospitalization | discharge, up to end of hospitalization (Follow-up up to 5 days) | 
| duration of mechanical ventilation | number of days between inclusion and the end of hospitalization | discharge, up to end of hospitalization (Follow-up up to 5 days) | 
| Mechanical ventilation complication | the rate of occurrence of pneumopathy acquired under mechanical ventilation (between 3rd and 10th day of developmen | From the third to the tenth day after inclusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intensive Care Unit ; limb fracture ; regional analgesia