Back to results

PENG vs FICB for Hip Fracture in ED Patients

Primary Purpose

Femoral Neck Fractures, Intertrochanteric Fractures

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

PENG

FICB

About this trial

This is an interventional supportive care trial for Femoral Neck Fractures focused on measuring PENG, FICB, Fascia Iliaca Compartment Block, Pericapsular Nerve Group Block, Hip fracture

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

University of Virginia Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

PENG

FICB

Arm Description

Patients with hip fracture randomized to receive PENG block

Patients with hip fracture randomized to received FICB

Outcomes

Primary Outcome Measures

Pain score

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

Mean opioid consumption in morphine equivalents

Full Information

NCT ID

NCT05505604

First Posted

August 15, 2022

Last Updated

May 8, 2023

Sponsor

University of Virginia

1. Study Identification

Unique Protocol Identification Number

NCT05505604

Brief Title

PENG vs FICB for Hip Fracture in ED Patients

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 30, 2022 (Actual)

Primary Completion Date

September 30, 2023 (Anticipated)

Study Completion Date

September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Virginia

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Femoral Neck Fractures, Intertrochanteric Fractures

Keywords

PENG, FICB, Fascia Iliaca Compartment Block, Pericapsular Nerve Group Block, Hip fracture

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

PENG

Arm Type

Active Comparator

Arm Description

Patients with hip fracture randomized to receive PENG block

Arm Title

FICB

Arm Type

Active Comparator

Arm Description

Patients with hip fracture randomized to received FICB

Intervention Type

Procedure

Intervention Name(s)

PENG

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

FICB

Intervention Description

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

Primary Outcome Measure Information:

Title

Pain score

Description

Mean pain score on a 100 mm VAS Range 0-100 mm with 0 representing no pain and 100 mm representing severe pain

Time Frame

6 hours

Secondary Outcome Measure Information:

Title

Opioid use

Description

Mean opioid consumption in morphine equivalents

Time Frame

6 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

University of Virginia Medical Center

City

Charlottesville

State/Province

Virginia

ZIP/Postal Code

22908

Country

United States

Individual Site Status

Recruiting

Facility Contact: