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OpenTrials
Completed

NCT Number: NCT04278807

PENG-block Versus FIB-block in Emergency Room

The trial aims to verify a possible greater analgesic efficacy of PENG (Pericapsular Nerve Group) block compared to iliac fascia block (FIB block) in elderly patients (age > 65 years) suffering from traumatic fracture of proximal femur in emergency room.

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Key information

Age range

65 year–105 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Santo Spirito Hospital

Rome, Italy

About this study

Prospective randomized double-blind single-center preliminary study aimed to demonstrate a possible greater analgesic efficacy of the PENG block compared to the iliac fascia block (FIB block) in elderly patients (age > 65 years) suffering from traumatic fracture of the proximal femur in emergency room.

The study will cover patients aged > 65 years suffering from a proximal traumatic fracture of the femur who access the emergency room of Santo Spirito Hospital in Rome (ASL Roma 1).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • all patients > 65 years suffering from a proximal traumatic fracture of a femur who access the emergency room of Santo Spirito Hospital in Rome (ASL Rome 1), for whom surgical treatment of osteosynthesis is recommended within 48 hours in accordance with the guidelines of Regional Health System (Regione Lazio).

Exclusion criteria

  • Failure to acquire written and valid informed consent
  • ASA > 3
  • Obesity (BMI> 35 kg / m2)
  • Contraindications to performing regional anesthesia (severe coagulopathies and / or thrombocytopenia, septic state and / or infections at the block site, allergy to local anesthetics)
  • Patients on therapy with antiplatelet agents, anticoagulants or who regularly use opioids, NSAIDs, acetaminophen for chronic painful conditions;
  • History of alcohol or drug abuse;
  • Severe kidney or liver failure;
  • Cognitive alterations, dementia, psychiatric pathologies

Treatment and study plan

Regional Anesthesia - Nerve Blocks

Procedure

Regional Anesthesia and ultrasound-guided nerve blocks

Primary outcomes

  1. Evaluation of success rate of PENG block (defined as NRS score </ = 4 at 30 minutes from the blockade placement by comparing it to the analgesic effect of the FIB block, also evaluated at 30 minutes as NRS score </ = 4).

    Time frame: 30 minutes after the placement of nerve block

    Numeric Rating Scale (NRS-score) evaluation, from 0 (no pain) to 10 (worst pain).

Secondary outcomes

  1. Onset time and duration of nerve blockade

    Time frame: from 30 minutes to 12 hours

    First request of analgesic medication after blockade

  2. Evaluation of rest and incident pain

    Time frame: 30 minutes after the placement of nerve block

    Numeric Rating Scale (NRS-score) evaluation, from 0 (no pain) to 10 (worst pain)

  3. Use of rescue-medication in pain treatment

    Time frame: from 30 minutes to 12 hours

    Analgesic drugs administered at the request of the patient in the case of blockade failure

  4. Check for any complications related to analgesic (PENG and FIB) blocks

    Time frame: from 30 minutes to 12 hours

    Recording of any complications related to PENG and FIB blocks

Sponsors and collaborators

Lead sponsor

Santo Spirito Hospital, Italy

Other

Registry information

Official study title

Analgesic Efficacy of PENG Block Compared to FIB Block in the Elderly Patient With Fracture of the Proximal Femur in the Emergency Room

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 20, 2020
Registry last updated
Sep 21, 2021

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.