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

Last updated: September 27, 2024
Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
Overall Status: Completed

Phase

N/A

Condition

Osteoporosis

Treatment

Infrainguinal Fascia Iliaca Block

Pericapsular nerve Group Block

Clinical Study ID

NCT05370586
0020199/22
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

  • Age >18

  • Capacity to understand the aim of the study, the potential benefits and side-effectsof 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 ordynamic)

Exclusion

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)

Study Design

Total Participants: 64
Treatment Group(s): 2
Primary Treatment: Infrainguinal Fascia Iliaca Block
Phase:
Study Start date:
July 30, 2022
Estimated Completion Date:
August 16, 2024

Connect with a study center

  • Emergency Department, IRCCS San Matteo University Hospital

    Pavia, Lombardia 27100
    Italy

    Site Not Available

  • Emergency Department, Colchester General Hospital

    Colchester,
    United Kingdom

    Site Not Available

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