PENG vs FICB for Hip Fracture in ED Patients

Sponsor

University of Virginia (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05505604

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Regional anesthesia for hip fractures has been shown to decrease rates of delirium in elderly patients with hip fractures as well as improve pain compared to systemic opioids. The Pericapsular Nerve Group (PENG) block has recently received attention as an alternative approach to femoral nerve block and Fascia Iliaca Compartment Block (FICB). The investigators seek to evaluate if there is a difference between the PENG and FICB in terms of efficacy of pain control in ED patients presenting with hip fracture. We hypothesize that the PENG block may be superior based on previous research.

Condition or Disease	Intervention/Treatment	Phase
Femoral Neck Fractures Intertrochanteric Fractures	Procedure: PENG Procedure: FICB	N/A

Detailed Description

Fractures of the proximal femur are a common presentation to the emergency department and are an acutely painful condition. This condition predominantly affects elderly patients who are at risk for delirium and more susceptible to the adverse effects of systemic opioids. Regional anesthesia is an recommended component of pain control for elderly patients with hip fracture. The investigators seek to compare the efficacy of pain control of the Pericapsular Nerve Group (PENG) block with the Fascia Iliaca Compartment Block (FICB).

Previous studies have suggested that the PENG block may be superior to the FICB for pain control and results in less thigh motor weakness. The investigators will compare pain control (by difference in mean VAS score at set time points), systemic opioid use (in mean morphine equivalents prior to surgery), and motor function in patients with hip fractures who receive either block in the ED.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Patients will be randomized to receive either a PENG or FICB. Baseline characteristics will be collected and VAS pain scores collected preblock and at specified time points post block.Patients will be randomized to receive either a PENG or FICB. Baseline characteristics will be collected and VAS pain scores collected preblock and at specified time points post block.

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Comparison of Pericapsular Nerve Group Block (PENG) Versus Fascia Iliaca Compartment Block (FICB) for Hip Fracture Analgesia in Emergency Department Patients

Anticipated Study Start Date :

Sep 30, 2022

Anticipated Primary Completion Date :

Sep 30, 2023

Anticipated Study Completion Date :

Sep 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: PENG Patients with hip fracture randomized to receive PENG block	Procedure: PENG patients will receive an ultrasound-guided Pericapsular Nerve Group Block with 20mL of 0.25% bupivacaine (not to exceed 2mg/kg)
Active Comparator: FICB Patients with hip fracture randomized to received FICB	Procedure: FICB Patients will receive an ultrasound-guided Fascia Iliaca Compartment Block with 20 mL of 0.25% bupivacaine (not to exceed 2 mg/kg) diluted to total volume of 40 mL of injectate

Arm

Intervention/Treatment

Active Comparator: PENG

Patients with hip fracture randomized to receive PENG block

Procedure: PENG

patients will receive an ultrasound-guided Pericapsular Nerve Group Block with 20mL of 0.25% bupivacaine (not to exceed 2mg/kg)

Active Comparator: FICB

Patients with hip fracture randomized to received FICB

Procedure: FICB

Patients will receive an ultrasound-guided Fascia Iliaca Compartment Block with 20 mL of 0.25% bupivacaine (not to exceed 2 mg/kg) diluted to total volume of 40 mL of injectate

Outcome Measures

Primary Outcome Measures

Pain score [6 hours]
Mean pain score on a 100 mm VAS Range 0-100 mm with 0 representing no pain and 100 mm representing severe pain

Secondary Outcome Measures

Opioid use [6 hours]
Mean opioid consumption in morphine equivalents

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Proximal femur fracture

Exclusion Criteria:

refusal to consent
hemodynamic instability
allergy to local anesthetics
severe injury with instability
severe medical conditions with instability

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Virginia Medical Center	Charlottesville	Virginia	United States	22908

Sponsors and Collaborators

University of Virginia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Matthew Kongkatong, MD, Assistant Professor of Emergency Medicine, University of Virginia

ClinicalTrials.gov Identifier:

NCT05505604

Other Study ID Numbers:

HSR220275

First Posted:

Aug 18, 2022

Last Update Posted:

Aug 22, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Matthew Kongkatong, MD, Assistant Professor of Emergency Medicine, University of Virginia

PENG

FICB

Fascia Iliaca Compartment Block

Pericapsular Nerve Group Block

Hip fracture

Additional relevant MeSH terms:

Fractures, Bone

Hip Fractures

Femoral Neck Fractures

Study Results

No Results Posted as of Aug 22, 2022