Impact of Continuous Regional Analgesia in Severe Trauma Patients

NCT ID: NCT04546503

Last Updated: 2020-09-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-01
• Study Completion Date: 2014-07-31

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.

Conditions

Limb Fracture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Control Group

Intervention Type: PROCEDURE

General anaesthesia without regional analgesia

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

Group Type: EXPERIMENTAL

Continuous Regional analgesia

Intervention Type: 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

Interventions

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

Intervention Type: PROCEDURE

Control Group

General anaesthesia without regional analgesia

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 183 Months
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Oriane MARTINEZ, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesia Resuscitation at the Hospital Lapeyronie

Locations

University hospital

Montpellier, , France

Countries

France

Other Identifiers

2010-A00443-36

Identifier Type: OTHER

Identifier Source: secondary_id

8822

Identifier Type: -

Identifier Source: org_study_id