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

NCT06707558 | Not Yet Recruiting

• 1 other identifier: ASO.AnRi.24.03
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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).

  One hour after the end of the procedure

Secondary Outcomes (5)

• Incidence of complications

  7 days after the end of the procedure

• Time of procedure

  At the end of the procedure

• Patient satisfaction

  one hour after the end of the procedure

• Operator satisfaction

  After the end of the procedure

• Pain before the PNB procedure

  Before the PNB procedure

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Approximately 500 patients entering the emergency department with ≤2 trauma fractures are expected to be enrolled, who undergo PNB

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria: lead

Study Sites (1)

Clinical Trial Center

Alessandria, Italy

Location

MeSH Terms

Conditions

Emergencies; Acute Pain; Wounds and Injuries

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

Mirco Leo, Anesthesiologist

CONTACT

0131208119; mirco.leo@ospedale.al.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: November 27, 2024
• Study Start: December 10, 2024
• Primary Completion: September 30, 2025
• Study Completion: December 31, 2025
• Last Updated: November 29, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)