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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-A00443-36 | Other Identifier | ID RCB |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous Regional Analgesia group | Active Comparator | 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 |
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| Control Group | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous Regional analgesia | Procedure | 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 |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Oriane MARTINEZ, MD | Department of Anesthesia Resuscitation at the Hospital Lapeyronie | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University hospital | Montpellier | 34295 | France |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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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
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The investigator responsible for assessing sedation and adjusting dosages hypnotic and morphinic (according to objectives) will not be aware of the result of the randomization.
|
| Control Group | Procedure | General anaesthesia without regional analgesia |
|
| 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 |
| D008722 | Methods |