EmergencyED-RANCT06707558
Italian Data Registry of Patients Undergoing Peripheral Nerve Block Performed in the Emergency Departments
An observational study of Emergency and Point of Care Ultrasound (POCUS), run by Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria at 1 site in Italy.
Trial summary
This data registry aim is to describe the practice of Point-of-Care Ultrasound Guided Regional Anaesthesia (POCUS-GRA) in emergency departments of nosocomial hospitals where, the organizational structure, has already provided for the implementation of peripheral nerve blocks (PNB) in common clinical practice for the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Emergency, Point of Care Ultrasound (POCUS), Anesthesia
- How many people
- 500 participants
- Where
- 1 siteItaly
- Study dates
- 10 Dec 2024to 31 Dec 2025
- How long will I take part?
- 7 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Approximately 500 patients entering the emergency department with ≤2 trauma fractures are expected to be enrolled, who undergo PNB
Who may be able to join
- Age ≥18 years;
- NRS>3
- Patients with traumatic fractures of ≤2 districts (radiologically confirmed (RX or CT). Districts are:
- Chest (one hemilateral) Pelvis (one hemilateral) Femur Leg Ankle Foot Shoulder Humerus Forearm Hand/fingers
- Presence of written informed consent to the study.
Who cannot join
- Intubated patients
- Patients with known dementia
- Patients with delirium (assessed by Confusion Assessment Method)
- Pregnant patients
- Patients with allergies to local anesthetics
- Patients unable to adequately communicate pain
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Clinical Trial Center
Alessandria
Clinical Trial Center, 0131206893, clinicaltrialcenter@ospedale.al.it
Mirco Leo, Anesthesiologist
About this study
This data registry aim is to describe the practice of Point-of-Care Ultrasound Guided Regional Anaesthesia (POCUS-GRA) in emergency departments of nosocomial hospitals where, the organizational structure, has already provided for the implementation of peripheral nerve blocks (PNB) in common clinical practice for the treatment of acute pain due to bone fractures.
Read the detailed description
Pain in emergency departments (EDs) is often inadequately treated. The consequences of inadequate treatment of pain defined as "oligoanalgesia," can have a negative impact on patient outcomes. The main reasons for this include lack of appropriate pathways, incorrect habits and aversion to opioid use. Pain is a symptom present in 78% of patients entering emergency departments, and among the main causes is trauma. A multimodal approach to pain treatment is more effective and minimizes side effects such as nausea, vomiting, and drowsiness due to the use of some drugs such as opioids. Over the past fifteen years, numerous studies have demonstrated the effectiveness of pain treatment using Point-of-Care Ultrasound Guided Regional Anaesthesia (POCUS-GRA) even outside the operating room. This data registry aim is to describe the practice of Point-of-Care Ultrasound Guided Regional Anaesthesia (POCUS-GRA) in emergency departments of nosocomial hospitals where, the organizational structure, has already provided for the implementation of peripheral nerve blocks (PNB) in common clinical practice for the treatment of acute pain due to bone fractures.
- Conditions
- Emergency, Point of Care Ultrasound (POCUS), Anesthesia, Acute Pain, Trauma
- Medical subject headings
- Emergencies, Acute Pain, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients from emergency department undergoing peripheral nerve blockade (PNB) | Patients admitted to the emergency department with ≤2 trauma fractures who undergo peripheral nerve blockade (PNB) will be enrolled |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minimally Clinically Important Difference
The percentage of patients, relative to the total, in whom the PNB (Peripheral Nerve Block) resulted in a reduction of at least 3 points in the VAS, defined as the MCID (Minimally Clinically Important Difference).
Measured: One hour after the end of the procedure
Secondary outcomes (5)
Incidence of complications
The number of complications associated with the procedure, such as: presence of bleeding, pneumothorax, neurological complications, neurological complications, presence of nerve damage.
Measured: 7 days after the end of the procedure
Time of procedure
The time required in minutes for the preparation and execution of the PNB
Measured: At the end of the procedure
Patient satisfaction
Assessment of patient satisfaction about analgesia according to a 5-point Likert scale item from 1 (very unsatisfied) to 5 (very satisfied)
Measured: one hour after the end of the procedure
Operator satisfaction
Assessment of satisfaction of the operator performing fracture reduction According to Likert 5-item scale from 1 (very unsatisfied) to 5 (very satisfied)
Measured: After the end of the procedure
Pain before the PNB procedure
Pain assessment before PNB performance, according to the VAS scale, from 0 (no pain) to 10 (worst pain possible)
Measured: Before the PNB procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study start10 Dec 2024 (estimated)
- Primary completion30 Sep 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EmergencyStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06707558
- Sponsor's protocol ID
- ASO.AnRi.24.03
- Acronym
- ED-RA
- Status last verified
- Nov 2024
- First submitted
- 25 Nov 2024
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Italian Data Registry of Patients Undergoing Peripheral Nerve Block Performed in the Emergency Departments
- ClinicalTrials.gov ID
- NCT06707558
- Acronym / sponsor ID
- ED-RA / ASO.AnRi.24.03
- Conditions
- Emergency, Point of Care Ultrasound (POCUS), Anesthesia, Acute Pain, Trauma
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di AlessandriaUniversity, hospital or other
- Study start
- 10 Dec 2024 (estimated)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 27 Nov 2024 (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.
This data registry aim is to describe the practice of Point-of-Care Ultrasound Guided Regional Anaesthesia (POCUS-GRA) in emergency departments of nosocomial hospitals where, the organizational structure, has already provided for the implementation of peripheral nerve blocks (PNB) in common clinical practice for the treatment of acute pain due to bone fractures.
Detailed description
Pain in emergency departments (EDs) is often inadequately treated. The consequences of inadequate treatment of pain defined as "oligoanalgesia," can have a negative impact on patient outcomes. The main reasons for this include lack of appropriate pathways, incorrect habits and aversion to opioid use. Pain is a symptom present in 78% of patients entering emergency departments, and among the main causes is trauma. A multimodal approach to pain treatment is more effective and minimizes side effects such as nausea, vomiting, and drowsiness due to the use of some drugs such as opioids. Over the past fifteen years, numerous studies have demonstrated the effectiveness of pain treatment using Point-of-Care Ultrasound Guided Regional Anaesthesia (POCUS-GRA) even outside the operating room. This data registry aim is to describe the practice of Point-of-Care Ultrasound Guided Regional Anaesthesia (POCUS-GRA) in emergency departments of nosocomial hospitals where, the organizational structure, has already provided for the implementation of peripheral nerve blocks (PNB) in common clinical practice for the treatment of acute pain due to bone fractures.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 7 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients from emergency department undergoing peripheral nerve blockade (PNB) | – | –Patients admitted to the emergency department with ≤2 trauma fractures who undergo peripheral nerve blockade (PNB) will be enrolled |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Approximately 500 patients entering the emergency department with ≤2 trauma fractures are expected to be enrolled, who undergo PNB
Key inclusion criteria (5 listed)
- Age ≥18 years;
- NRS>3
- Patients with traumatic fractures of ≤2 districts (radiologically confirmed (RX or CT). Districts are:
- Chest (one hemilateral) Pelvis (one hemilateral) Femur Leg Ankle Foot Shoulder Humerus Forearm Hand/fingers
- Presence of written informed consent to the study.
Key exclusion criteria (6 listed)
- Intubated patients
- Patients with known dementia
- Patients with delirium (assessed by Confusion Assessment Method)
- Pregnant patients
- Patients with allergies to local anesthetics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Minimally Clinically Important Difference
Time frame: One hour after the end of the procedure
The percentage of patients, relative to the total, in whom the PNB (Peripheral Nerve Block) resulted in a reduction of at least 3 points in the VAS, defined as the MCID (Minimally Clinically Important Difference).
5 secondary outcomes
Incidence of complications
Time frame: 7 days after the end of the procedure
Time of procedure
Time frame: At the end of the procedure
Patient satisfaction
Time frame: one hour after the end of the procedure
Operator satisfaction
Time frame: After the end of the procedure
Pain before the PNB procedure
Time frame: Before the PNB procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Emergency and Point of Care Ultrasound (POCUS), run by Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria at 1 site in Italy.
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 5 inclusion and 6 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: opening soon, as of the sponsor's last update on 29 Nov 2024. 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mirco Leo, Anesthesiologist (0131208119, mirco.leo@ospedale.al.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Minimally Clinically Important Difference (time frame: One hour after the end of the procedure). 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 29 Nov 2024.