Ignite Creation Date:
2025-12-24 @ 7:16 PM
Ignite Modification Date:
2025-12-31 @ 4:45 AM
Study NCT ID:
NCT04546503
Status:
COMPLETED
Last Update Posted:
2020-09-14
First Post:
2017-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Continuous Regional Analgesia in Severe Trauma Patients
Sponsor:
University Hospital, Montpellier
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ALRréa
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2010-A00443-36 | OTHER | ID RCB | View |