Clinical trial NCT05370586: PENG Block vs Fascia Iliaca Block for Emergency Department Analgesia in Hip Fractures
Official title: Pericapsular Nerve Group (PENG) Block Versus Fascia Iliaca (FIB) Block for Emergency Department Analgesia in Hip Fractures: A Randomised Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Fractures
Keywords: Fascia iliaca block
PENG block
Regional anaesthesia at Emergency Departments
Hip Fracture Analgesia
Lead sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
Sponsor class: OTHER
Collaborators: name: Colchester General Hospital
First posted: 2022-05-11
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: andomised-controlled trial with two parallel study groups. Participants will be randomised 1:1 to the study or control group. The study group will be treated with PENG block following randomisation, whereas the control group will receive the standard treatment, i.e., fascia iliaca block.

The study aims to demonstrate the superiority of the new intervention over the standard approach.
Primary purpose: TREATMENT

Brief summary: Pain management is a crucial aspect of the care of hip fracture patients. Patients with poorly controlled pain have an increased risk of delirium, long-term functional impairment, and remain hospitalized longer. Today, to relieve hip fracture pain, fascia iliaca block is routinely performed in the emergency department in addition to other pain medications administered by vein or by mouth. Several studies have questioned the analgesic efficacy of this block, suggesting the superiority of the newer PENG block. The purpose of this multicenter, randomized study is to compare the analgesic efficacy of PENG block versus fascia iliaca block, hypothesizing the superiority of the new approach over the gold standard. Participants will be blindly assigned in a 1:1 ratio to the study or control group, recruited from the Emergency Departments of IRCCS Policlinico San Matteo and Colchester Hospital (UK).

The main outcome is represented by the reduction of pain after the two blocks, measured as %SPID (percentage of "pain intensity difference"), a value derived from VAS scale measurements in the first hour post-procedure. Secondly, we will evaluate the proportion of patients with satisfactory pain control, the amount of opioids used and the safety profile of the two approaches.


Eligibility criteria: Inclusion Criteria:

* Age \>18
* Capacity to understand the aim of the study, the potential benefits and side-effects of the procedures
* Capacity to provide consent
* Capacity to provide a self-assessment of pain using the written VAS Scale
* Confirmed radiological diagnosis of hip fractures (including subcapitate, transcervical, intertrochanteric and perthrocanteric fractures)
* Moderate or severe worst pain (visual analogue scale, VAS \>40 mm) (at rest or dynamic)

Exclusion Criteria:

* Known hypersensitivity to local anaesthetics
* Confirmed radiological diagnosis of subtrochanteric or diaphyseal femur fractures
* Hemodynamic instability
* Known diagnosis of severe cognitive impairment
* Dementia and/or delirium (defined by a 4AT score ≥ 2)
* Lack of capacity to provide consent and to understand the aim of the study
* BMI\>35
* Body weight \< 40 Kg
* Prior hip surgery on the same fracture side
* Mild worst pain (visual analogue scale, VAS \< 40 mm) (at rest or dynamic)

Primary outcomes:
measure: Pain relief over the 60-minutes following either block measured as the percentage of summed pain-intensity difference (%SPID)
timeFrame: Outcome assessed within 60 minutes following the block (PENG or FIB)
Secondary outcomes:
measure: 33% SPID 33% (33%SPID)
timeFrame: Outcome assessed within 60 minutes following the block (PENG or FIB)
measure: 50%SPID
timeFrame: Outcome assessed within 60 minutes following the block (PENG or FIB)
measure: Quantity of opioids
timeFrame: Outcome assessed within 60 minutes following the block (PENG or FIB)
measure: Adverse events
timeFrame: Outcome assessed within 60 minutes following the block (PENG or FIB)
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Emergency Department, IRCCS San Matteo University Hospital
state: Lombardia
Study officials:
affiliation: IRCCS San Matteo Foundation - University of Pavia
name: Santi Di Pietro, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: