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

Not yet recruiting

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

• Registration Number: NCT06707558
• Lead Sponsor: Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria

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.

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-25
• Study First Submitted QC: 2024-11-25
• Last Update Submitted: 2024-11-26
• Study First Posted: 2024-11-27
• Last Update Posted: 2024-11-28
• Study Start: 2024-12-10
• Primary Completion: 2025-09-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Minimally Clinically Important Difference	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).

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction	one hour after the end of the procedure	Assessment of patient satisfaction about analgesia according to a 5-point Likert scale item from 1 (very unsatisfied) to 5 (very satisfied)
Incidence of complications	7 days after the end of the procedure	The number of complications associated with the procedure, such as: presence of bleeding, pneumothorax, neurological complications, neurological complications, presence of nerve damage.
Time of procedure	At the end of the procedure	The time required in minutes for the preparation and execution of the PNB
Operator satisfaction	After the end of the procedure	Assessment 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 procedure	Before the PNB procedure	Pain assessment before PNB performance, according to the VAS scale, from 0 (no pain) to 10 (worst pain possible)

Trial Locations

Locations (1)

Clinical Trial Center; 🇮🇹 Alessandria, Italy