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

Primary Purpose

Limb Fracture

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Continuous Regional analgesia
Control Group
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Limb Fracture focused on measuring Intensive Care Unit ; limb fracture ; regional analgesia

Eligibility Criteria

183 Months - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Continuous Regional Analgesia group

Control Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

daily consumption of sufentanil
daily consumption of sufentanil (mcg/kg/j)
daily consumption of sufentanil
daily consumption of sufentanil (mcg/kg/j)
daily consumption of sufentanil
daily consumption of sufentanil (mcg/kg/j)
daily consumption of sufentanil
daily consumption of sufentanil (mcg/kg/j)
daily consumption of sufentanil
daily consumption of sufentanil (mcg/kg/j)
daily consumption of midazolam
daily consumption of midazolam (mg/kg/j)
daily consumption of midazolam
daily consumption of midazolam (mg/kg/j)
daily consumption of midazolam
daily consumption of midazolam (mg/kg/j)
daily consumption of midazolam
daily consumption of midazolam (mg/kg/j)
daily consumption of midazolam
daily consumption of midazolam (mg/kg/j)
daily consumption of noradreline
daily consumption of noradreline (mg/kg/j)
daily consumption of noradreline
daily consumption of noradreline (mg/kg/j)
daily consumption of noradreline
daily consumption of noradreline (mg/kg/j)
daily consumption of noradreline
daily consumption of noradreline (mg/kg/j)
daily consumption of noradreline
daily consumption of noradreline (mg/kg/j)
sedation duration
number of days between inclusion and the end of hospitalization
ventilator free days
number of days between inclusion and the end of hospitalization
duration of mechanical ventilation
number of days between inclusion and the end of hospitalization
Mechanical ventilation complication
the rate of occurrence of pneumopathy acquired under mechanical ventilation (between 3rd and 10th day of developmen

Full Information

First Posted
October 19, 2017
Last Updated
September 4, 2020
Sponsor
University Hospital, Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT04546503
Brief Title
Impact of Continuous Regional Analgesia in Severe Trauma Patients
Acronym
ALRréa
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

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
June 1, 2014 (Actual)
Primary Completion Date
July 31, 2014 (Actual)
Study Completion Date
July 31, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Limb Fracture
Keywords
Intensive Care Unit ; limb fracture ; regional analgesia

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Investigator
Masking Description
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.
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Continuous Regional Analgesia group
Arm Type
Active Comparator
Arm Description
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
Arm Title
Control Group
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Continuous Regional analgesia
Intervention 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 + General anaesthesia
Intervention Type
Procedure
Intervention Name(s)
Control Group
Intervention Description
General anaesthesia without regional analgesia
Primary Outcome Measure Information:
Title
sufentanil consumption in ICU patients for sedation
Description
assess the interest of regional anesthesia in trauma patients with fractures members. sufentanil consumption in ICU patients for sedation (µg/kg/j)
Time Frame
up to 48 hours
Secondary Outcome Measure Information:
Title
daily consumption of sufentanil
Description
daily consumption of sufentanil (mcg/kg/j)
Time Frame
at 24 Hours
Title
daily consumption of sufentanil
Description
daily consumption of sufentanil (mcg/kg/j)
Time Frame
48 Hours
Title
daily consumption of sufentanil
Description
daily consumption of sufentanil (mcg/kg/j)
Time Frame
at 72 Hours
Title
daily consumption of sufentanil
Description
daily consumption of sufentanil (mcg/kg/j)
Time Frame
at 96 Hours
Title
daily consumption of sufentanil
Description
daily consumption of sufentanil (mcg/kg/j)
Time Frame
at 120 Hours
Title
daily consumption of midazolam
Description
daily consumption of midazolam (mg/kg/j)
Time Frame
at 24 Hours
Title
daily consumption of midazolam
Description
daily consumption of midazolam (mg/kg/j)
Time Frame
at 48 Hours
Title
daily consumption of midazolam
Description
daily consumption of midazolam (mg/kg/j)
Time Frame
at 72 Hours
Title
daily consumption of midazolam
Description
daily consumption of midazolam (mg/kg/j)
Time Frame
at 96 Hours
Title
daily consumption of midazolam
Description
daily consumption of midazolam (mg/kg/j)
Time Frame
at 120 Hours
Title
daily consumption of noradreline
Description
daily consumption of noradreline (mg/kg/j)
Time Frame
at 24 Hours
Title
daily consumption of noradreline
Description
daily consumption of noradreline (mg/kg/j)
Time Frame
at 48 Hours
Title
daily consumption of noradreline
Description
daily consumption of noradreline (mg/kg/j)
Time Frame
at 72 Hours
Title
daily consumption of noradreline
Description
daily consumption of noradreline (mg/kg/j)
Time Frame
at 96 Hours
Title
daily consumption of noradreline
Description
daily consumption of noradreline (mg/kg/j)
Time Frame
at 120 Hours
Title
sedation duration
Description
number of days between inclusion and the end of hospitalization
Time Frame
discharge, up to end of hospitalization (Follow-up up to 5 days)
Title
ventilator free days
Description
number of days between inclusion and the end of hospitalization
Time Frame
discharge, up to end of hospitalization (Follow-up up to 5 days)
Title
duration of mechanical ventilation
Description
number of days between inclusion and the end of hospitalization
Time Frame
discharge, up to end of hospitalization (Follow-up up to 5 days)
Title
Mechanical ventilation complication
Description
the rate of occurrence of pneumopathy acquired under mechanical ventilation (between 3rd and 10th day of developmen
Time Frame
From the third to the tenth day after inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
183 Months
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oriane MARTINEZ, MD
Organizational Affiliation
Department of Anesthesia Resuscitation at the Hospital Lapeyronie
Official's Role
Principal Investigator
Facility Information:
Facility Name
University hospital
City
Montpellier
ZIP/Postal Code
34295
Country
France

12. IPD Sharing Statement

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Impact of Continuous Regional Analgesia in Severe Trauma Patients

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