PENG Block vs Fascia Iliaca Block for Emergency Department Analgesia in Hip Fractures

NCT05370586 | Completed

• 1 other identifier: 0020199/22
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Hip Fractures

Keywords

Fascia iliaca block; PENG block; Regional anaesthesia at Emergency Departments; Hip Fracture Analgesia

Outcome Measures

Primary Outcomes (1)

• Pain relief over the 60-minutes following either block measured as the percentage of summed pain-intensity difference (%SPID)

  Pain relief over the 60-minutes following either block measured as the percentage of summed pain-intensity difference (%SPID) (derived from V AS measurement at T0-T1- T2-T3-T4 as described above)

  Outcome assessed within 60 minutes following the block (PENG or FIB)

Secondary Outcomes (4)

• 33% SPID 33% (33%SPID)

  Outcome assessed within 60 minutes following the block (PENG or FIB)

• 50%SPID

  Outcome assessed within 60 minutes following the block (PENG or FIB)

• Quantity of opioids

  Outcome assessed within 60 minutes following the block (PENG or FIB)

• Adverse events

  Outcome assessed within 60 minutes following the block (PENG or FIB)

Study Arms (2)

PENG block: Study group

EXPERIMENTAL

Patients enrolled in the study group will receive a PENG block with 20 mL of 0,375% levobupivacaine with 4 mg of dexamethasone. The block will be performed with the patient in a supine position using an 18-gauge, 90 mm needle, inserted with an in-plane lateral to medial approach. Operators will use the original technique described by Girón-Arango L et al. The aim of this block is to inject the local anaesthetic between the psoas tendon and the iliopubic eminence. We will instruct operators to routinely use a curvilinear probe (2-6 MHz) or a linear probe (4-16 MHz) in particularly lean or cachectic patients.

Other: Pericapsular nerve Group Block

Infrainguinal fascia iliaca block: Control group

OTHER

Patients allocated in the control group will receive an infrainguinal fascia iliaca block with 30 mL of 0,25 % levobupivacaine with 4 mg of dexamethasone, using an 18-gauge, 90 mm needle, inserted with an in-plane lateral to medial approach. The probe (linear 4-16 MHz) is placed transversely at the inguinal crease to identify the femoral artery, femoral nerve, iliopsoas muscle and the fascia iliaca over the psoas muscle. Moving the probe laterally the sartorius muscle and the anterior inferior iliac spine (AIIS) can be identified. After skin disinfection the needle is inserted placing the tip beneath the fascia iliaca at the lateral third of a line between the AIIS and pubic tubercle. Correct needle placement is confirmed by separation of the fascia iliaca from the iliopsoas muscle upon injection, with local anaesthetic spreading towards the FN medially and the iliac crest laterally.

Other: Infrainguinal Fascia Iliaca Block

Interventions

Pericapsular nerve Group Block OTHER

Patients of study group will receive PENG block with 20 mL of 0,375% levobupivacaine with 4 mg of dexamethasone

PENG block: Study group

Infrainguinal Fascia Iliaca Block OTHER

Patients of control group will receive an infrainguinal fascia iliaca block with 30 mL of 0,25 % levobupivacaine with 4 mg of dexamethasone

Infrainguinal fascia iliaca block: Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead
• Colchester General Hospital: collaborator

Study Sites (1)

Emergency Department, IRCCS San Matteo University Hospital

Pavia, Lombardy, 27100, Italy

Location

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• Santi Di Pietro, MD, PhD

  IRCCS San Matteo Foundation - University of Pavia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD - Emergency Medicine Consultant

Model Details: 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.

Study Record Dates

• First Submitted: May 7, 2022
• First Posted: May 11, 2022
• Study Start: July 30, 2022
• Primary Completion: August 16, 2024
• Study Completion: August 16, 2024
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)