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NCT Number: NCT06707558

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinical Trial Center

Alessandria, Italy

Location contact

Clinical Trial Center

CONTACT

[email protected]

0131206893

Mirco Leo, Anesthesiologist

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  1. Incidence of complications

    Time frame: 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.

  2. Time of procedure

    Time frame: At the end of the procedure

    The time required in minutes for the preparation and execution of the PNB

  3. Patient satisfaction

    Time frame: 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)

  4. Operator satisfaction

    Time frame: 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)

  5. Pain before the PNB procedure

    Time frame: Before the PNB procedure

    Pain assessment before PNB performance, according to the VAS scale, from 0 (no pain) to 10 (worst pain possible)

Study contacts

Contact information is provided by the study sponsor or research team.

Mirco Leo, Anesthesiologist

CONTACT

[email protected]

0131208119

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Acronym: ED-RA

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 27, 2024
Registry last updated
Nov 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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