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Italian Data Registry of Patients Undergoing Peripheral Nerve Block Performed in the Emergency Departments

Italian Data Registry of Patients Undergoing Peripheral Nerve Block Performed in the Emergency Departments

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06707558
Acronym
ED-RA
Enrollment
500
Registered
2024-11-27
Start date
2024-12-10
Completion date
2025-12-31
Last updated
2024-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Pain, Anesthesia, Emergency, Point of Care Ultrasound (POCUS), Trauma

Brief 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 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.

Interventions

None listed

Sponsors

Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Minimally Clinically Important DifferenceOne hour after the end of the procedureThe 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).

Secondary

MeasureTime frameDescription
Incidence of complications7 days after the end of the procedureThe number of complications associated with the procedure, such as: presence of bleeding, pneumothorax, neurological complications, neurological complications, presence of nerve damage.
Time of procedureAt the end of the procedureThe time required in minutes for the preparation and execution of the PNB
Patient satisfactionone hour after the end of the procedureAssessment of patient satisfaction about analgesia according to a 5-point Likert scale item from 1 (very unsatisfied) to 5 (very satisfied)
Operator satisfactionAfter the end of the procedureAssessment of satisfaction of the operator performing fracture reduction According to Likert 5-item scale from 1 (very unsatisfied) to 5 (very satisfied)
Pain before the PNB procedureBefore the PNB procedurePain assessment before PNB performance, according to the VAS scale, from 0 (no pain) to 10 (worst pain possible)

Countries

Italy

Contacts

Primary ContactMirco Leo, Anesthesiologist
mirco.leo@ospedale.al.it0131208119

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026