Limb FractureALRréaNCT04546503
Impact of Continuous Regional Analgesia in Severe Trauma Patients
A study testing Continuous Regional analgesia in people with Limb Fracture, run by University Hospital, Montpellier at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 183 months to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Limb Fracture
- What is being tested?
- Continuous Regional analgesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2014to 31 Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 183 months to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Tetraplegic Patient
- Dying patients
- Patients with more than 3 different fracture sites
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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
- Being tested
- Continuous Regional analgesia, Control Group
- Keywords
- Intensive Care Unit ; limb fracture ; regional analgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Regional analgesiaProcedure or surgery
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 GroupProcedure or surgery
General anaesthesia without regional analgesia
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: Continuous Regional analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: up to 48 hours
Secondary outcomes (19)
daily consumption of sufentanil
daily consumption of sufentanil (mcg/kg/j)
Measured: at 24 Hours
daily consumption of sufentanil
daily consumption of sufentanil (mcg/kg/j)
Measured: 48 Hours
daily consumption of sufentanil
daily consumption of sufentanil (mcg/kg/j)
Measured: at 72 Hours
daily consumption of sufentanil
daily consumption of sufentanil (mcg/kg/j)
Measured: at 96 Hours
daily consumption of sufentanil
daily consumption of sufentanil (mcg/kg/j)
Measured: at 120 Hours
daily consumption of midazolam
daily consumption of midazolam (mg/kg/j)
Measured: at 24 Hours
daily consumption of midazolam
daily consumption of midazolam (mg/kg/j)
Measured: at 48 Hours
daily consumption of midazolam
daily consumption of midazolam (mg/kg/j)
Measured: at 72 Hours
daily consumption of midazolam
daily consumption of midazolam (mg/kg/j)
Measured: at 96 Hours
daily consumption of midazolam
daily consumption of midazolam (mg/kg/j)
Measured: at 120 Hours
daily consumption of noradreline
daily consumption of noradreline (mg/kg/j)
Measured: at 24 Hours
daily consumption of noradreline
daily consumption of noradreline (mg/kg/j)
Measured: at 48 Hours
daily consumption of noradreline
daily consumption of noradreline (mg/kg/j)
Measured: at 72 Hours
daily consumption of noradreline
daily consumption of noradreline (mg/kg/j)
Measured: at 96 Hours
daily consumption of noradreline
daily consumption of noradreline (mg/kg/j)
Measured: at 120 Hours
sedation duration
number of days between inclusion and the end of hospitalization
Measured: discharge, up to end of hospitalization (Follow-up up to 5 days)
ventilator free days
number of days between inclusion and the end of hospitalization
Measured: discharge, up to end of hospitalization (Follow-up up to 5 days)
duration of mechanical ventilation
number of days between inclusion and the end of hospitalization
Measured: discharge, up to end of hospitalization (Follow-up up to 5 days)
Mechanical ventilation complication
the rate of occurrence of pneumopathy acquired under mechanical ventilation (between 3rd and 10th day of developmen
Measured: From the third to the tenth day after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2020
- Study start1 Jun 2014
- Primary completion31 Jul 2014
- Study completion31 Jul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Limb FractureStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Oriane MARTINEZ, MD, Principal investigator, Department of Anesthesia Resuscitation at the Hospital Lapeyronie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04546503
- Sponsor's protocol ID
- 8822
- Other IDs
- 2010-A00443-36
- Acronym
- ALRréa
- Status last verified
- Oct 2017
- First submitted
- 19 Oct 2017
- Last updated
- 14 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04546503
- Acronym / sponsor ID
- ALRréa / 8822
- Conditions
- Limb Fracture
- Keywords
- Intensive Care Unit ; limb fracture ; regional analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Jun 2014 (actual)
- Primary completion
- 31 Jul 2014 (actual)
- Study completion
- 31 Jul 2014 (actual)
- First posted
- 14 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Continuous Regional Analgesia group | Active comparator | Procedure: Control GroupSedation 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 |
| Control Group | Experimental | Procedure: Continuous Regional analgesiagroup 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 |
Who may qualify
- Ages
- 183 months to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous Regional analgesiaAseptic 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 | Procedure or surgery | Control Group |
| Control GroupGeneral anaesthesia without regional analgesia | Procedure or surgery | Continuous Regional Analgesia group |
Primary outcome
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)
19 secondary outcomes
daily consumption of sufentanil
Time frame: at 24 Hours
daily consumption of sufentanil
Time frame: 48 Hours
daily consumption of sufentanil
Time frame: at 72 Hours
daily consumption of sufentanil
Time frame: at 96 Hours
daily consumption of sufentanil
Time frame: at 120 Hours
daily consumption of midazolam
Time frame: at 24 Hours
daily consumption of midazolam
Time frame: at 48 Hours
daily consumption of midazolam
Time frame: at 72 Hours
daily consumption of midazolam
Time frame: at 96 Hours
daily consumption of midazolam
Time frame: at 120 Hours
daily consumption of noradreline
Time frame: at 24 Hours
daily consumption of noradreline
Time frame: at 48 Hours
daily consumption of noradreline
Time frame: at 72 Hours
daily consumption of noradreline
Time frame: at 96 Hours
daily consumption of noradreline
Time frame: at 120 Hours
sedation duration
Time frame: discharge, up to end of hospitalization (Follow-up up to 5 days)
ventilator free days
Time frame: discharge, up to end of hospitalization (Follow-up up to 5 days)
duration of mechanical ventilation
Time frame: discharge, up to end of hospitalization (Follow-up up to 5 days)
Mechanical ventilation complication
Time frame: From the third to the tenth day after inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oriane MARTINEZ, MD principal investigator
Department of Anesthesia Resuscitation at the Hospital Lapeyronie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Regional analgesia in people with Limb Fracture, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sufentanil consumption in ICU patients for sedation (time frame: up to 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2020.