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Completed

NCT Number: NCT04546503

Impact of Continuous Regional Analgesia in Severe Trauma Patients

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

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Key information

Conditions

Age range

183 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University hospital

Montpellier, 34295, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Control Group

Procedure

General anaesthesia without regional analgesia

Primary outcomes

  1. sufentanil consumption in ICU patients for sedation

    Time frame: up to 48 hours

    assess the interest of regional anesthesia in trauma patients with fractures members. sufentanil consumption in ICU patients for sedation (µg/kg/j)

Secondary outcomes

  1. daily consumption of sufentanil

    Time frame: at 24 Hours

    daily consumption of sufentanil (mcg/kg/j)

  2. daily consumption of sufentanil

    Time frame: 48 Hours

    daily consumption of sufentanil (mcg/kg/j)

  3. daily consumption of sufentanil

    Time frame: at 72 Hours

    daily consumption of sufentanil (mcg/kg/j)

  4. daily consumption of sufentanil

    Time frame: at 96 Hours

    daily consumption of sufentanil (mcg/kg/j)

  5. daily consumption of sufentanil

    Time frame: at 120 Hours

    daily consumption of sufentanil (mcg/kg/j)

  6. daily consumption of midazolam

    Time frame: at 24 Hours

    daily consumption of midazolam (mg/kg/j)

  7. daily consumption of midazolam

    Time frame: at 48 Hours

    daily consumption of midazolam (mg/kg/j)

  8. daily consumption of midazolam

    Time frame: at 72 Hours

    daily consumption of midazolam (mg/kg/j)

  9. daily consumption of midazolam

    Time frame: at 96 Hours

    daily consumption of midazolam (mg/kg/j)

  10. daily consumption of midazolam

    Time frame: at 120 Hours

    daily consumption of midazolam (mg/kg/j)

  11. daily consumption of noradreline

    Time frame: at 24 Hours

    daily consumption of noradreline (mg/kg/j)

  12. daily consumption of noradreline

    Time frame: at 48 Hours

    daily consumption of noradreline (mg/kg/j)

  13. daily consumption of noradreline

    Time frame: at 72 Hours

    daily consumption of noradreline (mg/kg/j)

  14. daily consumption of noradreline

    Time frame: at 96 Hours

    daily consumption of noradreline (mg/kg/j)

  15. daily consumption of noradreline

    Time frame: at 120 Hours

    daily consumption of noradreline (mg/kg/j)

  16. sedation duration

    Time frame: discharge, up to end of hospitalization (Follow-up up to 5 days)

    number of days between inclusion and the end of hospitalization

  17. ventilator free days

    Time frame: discharge, up to end of hospitalization (Follow-up up to 5 days)

    number of days between inclusion and the end of hospitalization

  18. duration of mechanical ventilation

    Time frame: discharge, up to end of hospitalization (Follow-up up to 5 days)

    number of days between inclusion and the end of hospitalization

  19. Mechanical ventilation complication

    Time frame: From the third to the tenth day after inclusion

    the rate of occurrence of pneumopathy acquired under mechanical ventilation (between 3rd and 10th day of developmen

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study 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

Acronym: ALRréa

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Sep 14, 2020
Registry last updated
Sep 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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