Clinical trial NCT04278807: PENG-block Versus FIB-block in Emergency Room
Official title: Analgesic Efficacy of PENG Block Compared to FIB Block in the Elderly Patient With Fracture of the Proximal Femur in the Emergency Room
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain Relief in Proximal Femoral Fracture
Lead sponsor: Santo Spirito Hospital, Italy
Sponsor class: OTHER
First posted: 2020-02-20
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Maximum age (years): 105
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: 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).
timeFrame: 30 minutes after the placement of nerve block
Secondary outcomes:
measure: Onset time and duration of nerve blockade
timeFrame: from 30 minutes to 12 hours
measure: Evaluation of rest and incident pain
timeFrame: 30 minutes after the placement of nerve block
measure: Use of rescue-medication in pain treatment
timeFrame: from 30 minutes to 12 hours
measure: Check for any complications related to analgesic (PENG and FIB) blocks
timeFrame: from 30 minutes to 12 hours
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Santo Spirito Hospital
Study officials:
affiliation: UOC Anestesia e Rianimazione Santo Spirito Hospital Rome
name: Francesco Marrone
role: PRINCIPAL_INVESTIGATOR
References: