Impact of Continuous Regional Analgesia in Severe Trauma Patients
Condition: Limb Fracture
MeSH terms: Fractures, Bone
Study type: Interventional

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.
    

Intervention name(s): Continuous Regional analgesia; Control Group
Intervention type(s): Procedure; Procedure
Intervention description(s): 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
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention 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 (Investigator)
Primary purpose: Other
Keywords: Intensive Care Unit ; limb fracture ; regional analgesia