PENG-block Versus FIB-block in Emergency Room

NCT ID: NCT04278807

Last Updated: 2021-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-14

Study Completion Date

2021-09-19

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).

Conditions

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Pain Relief in Proximal Femoral Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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PENG-group

Ultrasound-guided PENG-block - 30 patients

Group Type EXPERIMENTAL

Regional Anesthesia - Nerve Blocks

Intervention Type PROCEDURE

Regional Anesthesia and ultrasound-guided nerve blocks

FIB-group

Ultrasound-guided Fascia Iliaca block - 30 patients

Group Type EXPERIMENTAL

Regional Anesthesia - Nerve Blocks

Intervention Type PROCEDURE

Regional Anesthesia and ultrasound-guided nerve blocks

Interventions

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Regional Anesthesia - Nerve Blocks

Regional Anesthesia and ultrasound-guided nerve blocks

Intervention Type PROCEDURE

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
Minimum Eligible Age

65 Years

Maximum Eligible Age

105 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Santo Spirito Hospital, Italy

OTHER

Sponsor Role lead

Responsible Party

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Dr Francesco Marrone

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Francesco Marrone

Role: PRINCIPAL_INVESTIGATOR

UOC Anestesia e Rianimazione Santo Spirito Hospital Rome

Locations

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Santo Spirito Hospital

Rome, , Italy

Site Status

Countries

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Italy

Other Identifiers

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SSH_PENG_Trial

Identifier Type: -

Identifier Source: org_study_id

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