PENG-block Versus FIB-block in Emergency Room

Santo Spirito Hospital, Italy60 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Pain Relief in Proximal Femoral Fracture

Interventions

Regional Anesthesia - Nerve BlocksPROCEDURE

Regional Anesthesia and ultrasound-guided nerve blocks

Eligibility

Sex: ALLMin age: 65 YearsMax age: 105 Years

Medical Language ↔ Plain English

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

Locations (1)

Santo Spirito Hospital

Rome, Italy

Outcomes

Primary Outcomes

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).

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

Time frame: 30 minutes after the placement of nerve block

Secondary Outcomes

Onset time and duration of nerve blockade

First request of analgesic medication after blockade

Time frame: from 30 minutes to 12 hours

Evaluation of rest and incident pain

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

Time frame: 30 minutes after the placement of nerve block

Use of rescue-medication in pain treatment

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

Time frame: from 30 minutes to 12 hours

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

Recording of any complications related to PENG and FIB blocks

Time frame: from 30 minutes to 12 hours

Data from ClinicalTrials.gov

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