PENG-block Versus FIB-block in Emergency Room

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

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

Conditions
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Pain Relief in Proximal Femoral Fracture

Intervention / Treatment
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* Procedure: Regional Anesthesia - Nerve Blocks


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 105 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PENG-group<br>Ultrasound-guided PENG-block - 30 patients | Procedure: Regional Anesthesia - Nerve Blocks<br>* Regional Anesthesia and ultrasound-guided nerve blocks<br>|
| Experimental: FIB-group<br>Ultrasound-guided Fascia Iliaca block - 30 patients | Procedure: Regional Anesthesia - Nerve Blocks<br>* Regional Anesthesia and ultrasound-guided nerve blocks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 30 minutes after the placement of nerve block | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Onset time and duration of nerve blockade | First request of analgesic medication after blockade | 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) | 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 | 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 | from 30 minutes to 12 hours |