PENG vs. FIC Block for Hip Fracture ED Patients

Pericapsular Nerve Group (PENG) Block vs. the Fascia Iliaca Compartment (FIC) Block for Patients With Isolated Hip Fractures in the Emergency Department

Ultrasound-guided nerve blocks are an important tool for treating pain due to orthopedic injury in the ED. They provide long lasting, opioid-sparing pain relief that is generally safe and well-tolerated by patients1. Elderly patients with hip fractures commonly present to the ED, and their injury can be painful. Commonly used opioid pain regimens can have deleterious side effects, especially in elderly patients, like somnolence, delirium, hypotension and respiratory depression.

The fascia iliaca compartment (FIC) block has become a familiar technique to emergency physicians as a pain control treatment for hip fractures. The pericapsular nerve group (PENG) block has recently been proposed as a novel method to treat pain due to hip, acetabular and pelvic fracture by targeting the terminal sensory articular nerve branches of the femoral nerve (FN), obturator nerve (ON), and accessory obturator nerve (AON). At this time there has been no study comparing the efficacy of the two nerve blocks, PENG and FIC.

This aim of this study is to compare the efficacy of the PENG block (20mL of Bupivacaine 0.50%) to that of the FIC block (40mL of Bupivacaine 0.25%) for patients with hip fractures in the ED. Our hypothesis is that PENG will demonstrate analgesia that is non-inferior to FIC. Subjective pain scores on a scale of 0 to 10 will be assessed before and after the block. All subjects will receive 4mg of morphine after consent and prior to the block.

Study Overview

• Status: Recruiting
• Conditions: Pain; Hip Fracture
• Intervention / Treatment: Procedure: Nerve Block using FIC Proceedure; Procedure: Nerve Block using PENG Proceedure

Detailed Description

Ultrasound-guided nerve blocks are an important tool for treating pain due to orthopedic injury in the ED. They provide long lasting, opioid-sparing pain relief that is generally safe and well-tolerated by patients1. Elderly patients with hip fractures commonly present to the ED, and their injury can be painful. Commonly used opioid pain regimens can have deleterious side effects, especially in elderly patients, like somnolence, delirium, hypotension and respiratory depression.

The fascia iliaca compartment (FIC) block has become a familiar technique to emergency physicians as a pain control treatment for hip fractures. The pericapsular nerve group (PENG) block has recently been proposed as a novel method to treat pain due to hip, acetabular and pelvic fracture by targeting the terminal sensory articular nerve branches of the femoral nerve (FN), obturator nerve (ON), and accessory obturator nerve (AON). At this time there has been no study comparing the efficacy of the two nerve blocks, PENG and FIC.

This aim of this study is to compare the efficacy of the PENG block (20mL of Bupivacaine 0.50%) to that of the FIC block (40mL of Bupivacaine 0.25%) for patients with hip fractures in the ED. Our hypothesis is that PENG will demonstrate analgesia that is non-inferior to FIC. Subjective pain scores on a scale of 0 to 10 will be assessed before and after the block. All subjects will receive 4mg of morphine after consent and prior to the block.

A secondary aim is to show that the PENG block is preferable to the FIC block because it does not target motor nerves, thus preserving motor function allowing for an accurate neurological exam and hopefully providing for earlier ambulation. Also, we aim to determine if PENG block results in an significant reduction in amount of systemic pain medication needed for the patient.

This is a single-centered, prospective, randomized, blinded study involving patients who present to the ED with an isolated hip fracture. Patients who meet inclusion criteria will be consented for the study and then randomized to receive either a FIC block or a PENG block. Patients who are potentially to be enrolled in the study will receive standardized systemic analgesia while awaiting x-rays. If needed, patients will be administered morphine for breakthrough pain after the nerve blocks are placed. The exception to this standardization will be patients with a morphine allergy.

The research associate will screen for patients and confirm with the attending physician that the subject is eligible for enrollment and is able to give consent. The patient consented by a member of the research team, who will assess the patient's pain score on a scale of 0 to 10 prior to the block. The patient will then be randomized to receive either the FIC block or the PENG block to be performed by a member of the ultrasound faculty. The research associate will be blinded to the type of block being performed by the ultrasound faculty member. The research associate will then reassess the patient's pain score on the 0-10 scale at the 30 minute and 60-minute mark. They will also assess for any adverse events after the block is performed. The research associate will note the motor function in the quadriceps muscle 30 min and 60 min after the nerve block is placed. Any rescue medication given after the nerve block is placed in the ED will be recorded.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Antonios Likourezos, MPH; Phone Number: 718-283-6896; Email: alikourezos@maimonidesmed.org
• Study Contact Backup: Name: Lawrence Haines, MD; Phone Number: 718-283-6000; Email: LHaines@maimonidesmed.org

Study Locations

• United States
  • New York
    • Brooklyn, New York, United States, 11209
      • Recruiting
      • Maimonides Medical Center
      • Contact: Antonios Likourezos, MPH; Email: alikourezos@maimonidesmed.org
      • Contact: Lawrence Haines, MD; Email: LHaines@maimonidesmed.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 110 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult Emergency Medicine Patients over 18 years of age
• Isolated hip fracture, intertrocanteric or more proximal
• Pain score 5 or greater on a scale of 0 to 10 just prior to nerve block placement

Exclusion Criteria:

• Patients with multi-system trauma
• People who are unable to communicate their level of pain\
• Pregnant patients
• Pediatric Patients (less than 18 years of age)
• Intoxicated Patients
• Abnormal Vital Signs (HR>120bpm, MAP <65, Pulse Ox <95%)
• Patients on long term systemic opioid analgesia
• Allergy to amide local anesthetics

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Fascia Iliaca Compartment; Fascial Iliaca block (FIC) (40mL of Bupivacaine 0.25%) for patients with hip fractures in the ED	Procedure: Nerve Block using FIC Proceedure; Ultrasound Guided Nerve Block for Hip Fracture Patients using the FIC Proceedure
Active Comparator: PENG Block; Pericapsular Nerve Group (PENG) Block (20mL of Bupivacaine 0.50%)	Procedure: Nerve Block using PENG Proceedure; Ultrasound Guided Nerve Block for Hip Fractures Patients using the PENG Procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Score at 30 Minutes	The pain score at 11 point Likert Scale ranging 0 (no pain) to 10 (very severe pain) at 30 minutes post nerve block procedure	30 minutes post administration of nerve block

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Score at 60 minutes	The pain score at 11 point Likert Scale ranging 0 (no pain) to 10 (very severe pain) at 60 minutes post nerve block procedure	60 minutes post administration of nerve block

Collaborators and Investigators

• Sponsor: Antonios Likourezos
• Investigators: Principal Investigator: Lawrence Haines, MD, Maimonides Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2021
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: October 20, 2021
• First Submitted That Met QC Criteria: October 20, 2021
• First Posted (Actual): November 2, 2021

Study Record Updates

• Last Update Posted (Actual): July 5, 2023
• Last Update Submitted That Met QC Criteria: July 2, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Ultrasound; Pain; Hip Fracture; Nerve Block
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Fractures, Bone; Hip Fractures
• Other Study ID Numbers: 2021-02-09

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No