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PENG vs. FIC Block for Hip Fracture ED Patients

Primary Purpose

Pain, Hip Fracture

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nerve Block using FIC Proceedure
Nerve Block using PENG Proceedure
Sponsored by
Antonios Likourezos
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring Pain, Hip Fracture, Nerve Block, Ultrasound

Eligibility Criteria

18 Years - 110 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Maimonides Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Fascia Iliaca Compartment

PENG Block

Arm Description

Fascial Iliaca block (FIC) (40mL of Bupivacaine 0.25%) for patients with hip fractures in the ED

Pericapsular Nerve Group (PENG) Block (20mL of Bupivacaine 0.50%)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 20, 2021
Last Updated
July 2, 2023
Sponsor
Antonios Likourezos
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1. Study Identification

Unique Protocol Identification Number
NCT05102760
Brief Title
PENG vs. FIC Block for Hip Fracture ED Patients
Official Title
Pericapsular Nerve Group (PENG) Block vs. the Fascia Iliaca Compartment (FIC) Block for Patients With Isolated Hip Fractures in the Emergency Department
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 20, 2021 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Antonios Likourezos

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Hip Fracture
Keywords
Pain, Hip Fracture, Nerve Block, Ultrasound

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fascia Iliaca Compartment
Arm Type
Active Comparator
Arm Description
Fascial Iliaca block (FIC) (40mL of Bupivacaine 0.25%) for patients with hip fractures in the ED
Arm Title
PENG Block
Arm Type
Active Comparator
Arm Description
Pericapsular Nerve Group (PENG) Block (20mL of Bupivacaine 0.50%)
Intervention Type
Procedure
Intervention Name(s)
Nerve Block using FIC Proceedure
Intervention Description
Ultrasound Guided Nerve Block for Hip Fracture Patients using the FIC Proceedure
Intervention Type
Procedure
Intervention Name(s)
Nerve Block using PENG Proceedure
Intervention Description
Ultrasound Guided Nerve Block for Hip Fractures Patients using the PENG Procedure
Primary Outcome Measure Information:
Title
Pain Score at 30 Minutes
Description
The pain score at 11 point Likert Scale ranging 0 (no pain) to 10 (very severe pain) at 30 minutes post nerve block procedure
Time Frame
30 minutes post administration of nerve block
Secondary Outcome Measure Information:
Title
Pain Score at 60 minutes
Description
The pain score at 11 point Likert Scale ranging 0 (no pain) to 10 (very severe pain) at 60 minutes post nerve block procedure
Time Frame
60 minutes post administration of nerve block

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
110 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Antonios Likourezos, MPH
Phone
718-283-6896
Email
alikourezos@maimonidesmed.org
First Name & Middle Initial & Last Name or Official Title & Degree
Lawrence Haines, MD
Phone
718-283-6000
Email
LHaines@maimonidesmed.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lawrence Haines, MD
Organizational Affiliation
Maimonides Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maimonides Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11209
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonios Likourezos, MPH
Email
alikourezos@maimonidesmed.org
First Name & Middle Initial & Last Name & Degree
Lawrence Haines, MD
Email
LHaines@maimonidesmed.org

12. IPD Sharing Statement

Plan to Share IPD
No

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PENG vs. FIC Block for Hip Fracture ED Patients

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