Clinical trial NCT04546503: Impact of Continuous Regional Analgesia in Severe Trauma Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Limb Fracture
Keywords: Intensive Care Unit ; limb fracture ; regional analgesia
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2020-09-14
Enrollment: 80
Sex: ALL
Minimum age (years): 183
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: sufentanil consumption in ICU patients for sedation
timeFrame: up to 48 hours
Secondary outcomes:
measure: daily consumption of sufentanil
timeFrame: at 24 Hours
measure: daily consumption of sufentanil
timeFrame: 48 Hours
measure: daily consumption of sufentanil
timeFrame: at 72 Hours
measure: daily consumption of sufentanil
timeFrame: at 96 Hours
measure: daily consumption of sufentanil
timeFrame: at 120 Hours
measure: daily consumption of midazolam
timeFrame: at 24 Hours
measure: daily consumption of midazolam
timeFrame: at 48 Hours
measure: daily consumption of midazolam
timeFrame: at 72 Hours
measure: daily consumption of midazolam
timeFrame: at 96 Hours
measure: daily consumption of midazolam
timeFrame: at 120 Hours
measure: daily consumption of noradreline
timeFrame: at 24 Hours
measure: daily consumption of noradreline
timeFrame: at 48 Hours
measure: daily consumption of noradreline
timeFrame: at 72 Hours
measure: daily consumption of noradreline
timeFrame: at 96 Hours
measure: daily consumption of noradreline
timeFrame: at 120 Hours
measure: sedation duration
timeFrame: discharge, up to end of hospitalization (Follow-up up to 5 days)
measure: ventilator free days
timeFrame: discharge, up to end of hospitalization (Follow-up up to 5 days)
measure: duration of mechanical ventilation
timeFrame: discharge, up to end of hospitalization (Follow-up up to 5 days)
measure: Mechanical ventilation complication
timeFrame: From the third to the tenth day after inclusion
Other outcomes:
Locations:
city: Montpellier
country: France
facility: University hospital
Study officials:
affiliation: Department of Anesthesia Resuscitation at the Hospital Lapeyronie
name: Oriane MARTINEZ, MD
role: PRINCIPAL_INVESTIGATOR
References: