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Clinical Trials/NCT06707558
NCT06707558
Not yet recruiting
Not Applicable

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

Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria1 site in 1 country500 target enrollmentStarted: December 10, 2024Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
Enrollment
500
Locations
1
Primary Endpoint
Minimally Clinically Important Difference

Overview

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 Design

Study Type
Observational
Observational Model
Other
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Age ≥18 years;
  • 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

Outcomes

Primary Outcomes

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).

Secondary Outcomes

  • 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)

Investigators

Sponsor
Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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