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Completed

NCT Number: NCT05370586

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emergency Department, IRCCS San Matteo University Hospital

Pavia, Lombardy, 27100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

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

Primary outcomes

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

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

    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)

Secondary outcomes

  1. 33% SPID 33% (33%SPID)

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

    Number of patients who achieve a percentage of summed pain-intensity difference of 33% (33%SPID)

  2. 50%SPID

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

    Number of patients who achieve a percentage of summed pain-intensity difference of 50% (50%SPID)

  3. Quantity of opioids

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

    Quantity of opioids (milligrams of morphine) administered in the first 60 minutes following either block

  4. Adverse events

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

    Occurrence of adverse events including nausea or vomiting, hypotension, respiratory depression (hypoxia or hypopnea), local anaesthetic toxicity syndrome (LAST syndrome) during ED stay (post-block). Adverse event will be described, and their incidence will be presented with 95% CI and compared with Fisher test.

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Other

Collaborators

  • Colchester General Hospital

Registry information

Official study title

Pericapsular Nerve Group (PENG) Block Versus Fascia Iliaca (FIB) Block for Emergency Department Analgesia in Hip Fractures: A Randomised Controlled Trial.

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
May 11, 2022
Registry last updated
Oct 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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