Impact of Continuous Regional Analgesia in Severe Trauma Patients

Limb Fracture Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04546503
• Other study ID #: 8822
• Secondary ID: 2010-A00443-36
• Status: Completed
• Phase: N/A
• Start date: June 1, 2014
• Est. completion date: July 31, 2014

Study information

• Verified date: October 2017
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: July 31, 2014
• Est. primary completion date: July 31, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 183 Months to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Limb Fracture

Intervention

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
• Control Group
General anaesthesia without regional analgesia

Locations

Country	Name	City	State
France	University hospital	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	daily consumption of sufentanil	daily consumption of sufentanil (mcg/kg/j)	at 24 Hours
Secondary	daily consumption of sufentanil	daily consumption of sufentanil (mcg/kg/j)	48 Hours
Secondary	daily consumption of sufentanil	daily consumption of sufentanil (mcg/kg/j)	at 72 Hours
Secondary	daily consumption of sufentanil	daily consumption of sufentanil (mcg/kg/j)	at 96 Hours
Secondary	daily consumption of sufentanil	daily consumption of sufentanil (mcg/kg/j)	at 120 Hours
Secondary	daily consumption of midazolam	daily consumption of midazolam (mg/kg/j)	at 24 Hours
Secondary	daily consumption of midazolam	daily consumption of midazolam (mg/kg/j)	at 48 Hours
Secondary	daily consumption of midazolam	daily consumption of midazolam (mg/kg/j)	at 72 Hours
Secondary	daily consumption of midazolam	daily consumption of midazolam (mg/kg/j)	at 96 Hours
Secondary	daily consumption of midazolam	daily consumption of midazolam (mg/kg/j)	at 120 Hours
Secondary	daily consumption of noradreline	daily consumption of noradreline (mg/kg/j)	at 24 Hours
Secondary	daily consumption of noradreline	daily consumption of noradreline (mg/kg/j)	at 48 Hours
Secondary	daily consumption of noradreline	daily consumption of noradreline (mg/kg/j)	at 72 Hours
Secondary	daily consumption of noradreline	daily consumption of noradreline (mg/kg/j)	at 96 Hours
Secondary	daily consumption of noradreline	daily consumption of noradreline (mg/kg/j)	at 120 Hours
Secondary	sedation duration	number of days between inclusion and the end of hospitalization	discharge, up to end of hospitalization (Follow-up up to 5 days)
Secondary	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)
Secondary	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)
Secondary	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