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

Hip Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05370586
• Other study ID #: 0020199/22
• Status: Recruiting
• Phase: N/A
• Start date: July 30, 2022
• Est. completion date: March 2023

Study information

• Verified date: August 2022
• Source: IRCCS Policlinico S. Matteo
• Contact: Santi Di Pietro, MD
• Phone: 00393463153244
• Email: santi.dipietro01[@]universitadipavia.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: March 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Emergencies
• Fractures, Bone
• Hip Fractures

Intervention

Other:
• Pericapsular nerve Group Block
Patients of study group will receive PENG block with 20 mL of 0,375% levobupivacaine with 4 mg of dexamethasone
• Infrainguinal Fascia Iliaca Block
Patients of control group will receive an infrainguinal fascia iliaca block with 30 mL of 0,25 % levobupivacaine with 4 mg of dexamethasone

Locations

Country	Name	City	State
Italy	Emergency Department, IRCCS San Matteo University Hospital	Pavia	Lombardia
United Kingdom	Emergency Department, Colchester General Hospital	Colchester

Sponsors (2)

Lead Sponsor	Collaborator
IRCCS Policlinico S. Matteo	Colchester General Hospital

Countries where clinical trial is conducted

Italy,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	33% SPID 33% (33%SPID)	Number of patients who achieve a percentage of summed pain-intensity difference of 33% (33%SPID)	Outcome assessed within 60 minutes following the block (PENG or FIB)
Secondary	50%SPID	Number of patients who achieve a percentage of summed pain-intensity difference of 50% (50%SPID)	Outcome assessed within 60 minutes following the block (PENG or FIB)
Secondary	Quantity of opioids	Quantity of opioids (milligrams of morphine) administered in the first 60 minutes following either block	Outcome assessed within 60 minutes following the block (PENG or FIB)
Secondary	Adverse events	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.	Outcome assessed within 60 minutes following the block (PENG or FIB)