Impact of Continuous Regional Analgesia in Severe Trauma Patients (ALRréa)

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

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

Study Overview

• Status: Completed
• Conditions: Limb Fracture
• Intervention / Treatment: Procedure: Control Group; Procedure: Continuous Regional analgesia

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Continuous Regional Analgesia group; 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; General anaesthesia without regional analgesia
Experimental: Control Group; 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; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Principal Investigator: Oriane MARTINEZ, MD, Department of Anesthesia Resuscitation at the Hospital Lapeyronie

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2014
• Primary Completion (Actual): July 31, 2014
• Study Completion (Actual): July 31, 2014

Study Registration Dates

• First Submitted: October 19, 2017
• First Submitted That Met QC Criteria: September 4, 2020
• First Posted (Actual): September 14, 2020

Study Record Updates

• Last Update Posted (Actual): September 14, 2020
• Last Update Submitted That Met QC Criteria: September 4, 2020
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Intensive Care Unit ; limb fracture ; regional analgesia
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: 8822 (Other Identifier: CTEP); 2010-A00443-36 (Other Identifier: ID RCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No