PENG-block Versus FIB-block in Emergency Room

Not Applicable

Completed

• Conditions: Pain Relief in Proximal Femoral Fracture
• Interventions: Procedure: Regional Anesthesia - Nerve Blocks

• Registration Number: NCT04278807
• Lead Sponsor: Santo Spirito Hospital, Italy

Brief Summary

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

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 Timeline

• Study Start: 2020-02-14
• Study First Submitted: 2020-02-18
• Study First Submitted QC: 2020-02-18
• Study First Posted: 2020-02-20
• Status Verified: 2021-09
• Primary Completion: 2021-09-19
• Study Completion: 2021-09-19
• Last Update Submitted: 2021-09-20
• Last Update Posted: 2021-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PENG-group	Regional Anesthesia - Nerve Blocks	Ultrasound-guided PENG-block - 30 patients
FIB-group	Regional Anesthesia - Nerve Blocks	Ultrasound-guided Fascia Iliaca block - 30 patients

Primary Outcome Measures

Name	Time	Method
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).	30 minutes after the placement of nerve block	Numeric Rating Scale (NRS-score) evaluation, from 0 (no pain) to 10 (worst pain).

Secondary Outcome Measures

Name	Time	Method
Evaluation of rest and incident pain	30 minutes after the placement of nerve block	Numeric Rating Scale (NRS-score) evaluation, from 0 (no pain) to 10 (worst pain)
Check for any complications related to analgesic (PENG and FIB) blocks	from 30 minutes to 12 hours	Recording of any complications related to PENG and FIB blocks
Onset time and duration of nerve blockade	from 30 minutes to 12 hours	First request of analgesic medication after blockade
Use of rescue-medication in pain treatment	from 30 minutes to 12 hours	Analgesic drugs administered at the request of the patient in the case of blockade failure

Trial Locations

Locations (1)

Santo Spirito Hospital; 🇮🇹 Rome, Italy