PENG-block Versus FIB-block in Emergency Room

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

Study Overview

• Status: Completed
• Conditions: Pain Relief in Proximal Femoral Fracture
• Intervention / Treatment: Procedure: Regional Anesthesia - Nerve Blocks

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy
    • Santo Spirito Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 63 years to 103 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Santo Spirito Hospital, Italy
• Investigators: Principal Investigator: Francesco Marrone, UOC Anestesia e Rianimazione Santo Spirito Hospital Rome

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2020
• Primary Completion (Actual): September 19, 2021
• Study Completion (Actual): September 19, 2021

Study Registration Dates

• First Submitted: February 18, 2020
• First Submitted That Met QC Criteria: February 18, 2020
• First Posted (Actual): February 20, 2020

Study Record Updates

• Last Update Posted (Actual): September 21, 2021
• Last Update Submitted That Met QC Criteria: September 20, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Fractures, Bone; Wounds and Injuries; Leg Injuries; Disease Attributes; Femoral Fractures; Emergencies; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: SSH_PENG_Trial

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No