Impact of Continuous Regional Analgesia in Severe Trauma Patients

NCT04546503 | Completed DMC

• 2 other identifiers: 88222010-A00443-36
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Limb Fracture

Keywords

Intensive Care Unit ; limb fracture ; regional analgesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (19)

• daily consumption of sufentanil

  at 24 Hours

• daily consumption of sufentanil

  48 Hours

• daily consumption of sufentanil

  at 72 Hours

• daily consumption of sufentanil

  at 96 Hours

• daily consumption of sufentanil

  at 120 Hours

Study Arms (2)

Continuous Regional Analgesia group

ACTIVE COMPARATOR

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

Control Group

EXPERIMENTAL

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

Interventions

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

Control Group PROCEDURE

General anaesthesia without regional analgesia

Continuous Regional Analgesia group

Eligibility Criteria

• Age: 183 Months - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

University hospital

Montpellier, 34295, France

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Oriane MARTINEZ, MD

  Department of Anesthesia Resuscitation at the Hospital Lapeyronie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: October 19, 2017
• First Posted: September 14, 2020
• Study Start: June 1, 2014
• Primary Completion: July 31, 2014
• Study Completion: July 31, 2014
• Last Updated: September 14, 2020

Record last verified: 2017-10

Locations

FR (1)