NCT05102760

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
8mo left

Started Oct 2021

Longer than P75 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress88%
Oct 2021Dec 2026

First Submitted

Initial submission to the registry

October 20, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

October 20, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 2, 2021

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

September 25, 2025

Status Verified

September 1, 2025

Enrollment Period

4.7 years

First QC Date

October 20, 2021

Last Update Submit

September 23, 2025

Conditions

Keywords

PainHip FractureNerve BlockUltrasound

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Pain Score at 60 minutes

    60 minutes post administration of nerve block

Study Arms (2)

Fascia Iliaca Compartment

ACTIVE COMPARATOR

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

Procedure: Nerve Block using FIC Proceedure

PENG Block

ACTIVE COMPARATOR

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

Procedure: Nerve Block using PENG Proceedure

Interventions

Ultrasound Guided Nerve Block for Hip Fracture Patients using the FIC Proceedure

Fascia Iliaca Compartment

Ultrasound Guided Nerve Block for Hip Fractures Patients using the PENG Procedure

PENG Block

Eligibility Criteria

Age18 Years - 110 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maimonides Medical Center

Brooklyn, New York, 11209, United States

Location

MeSH Terms

Conditions

PainHip Fractures

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Officials

  • Lawrence Haines, MD

    Maimonides Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Administration Director

Study Record Dates

First Submitted

October 20, 2021

First Posted

November 2, 2021

Study Start

October 20, 2021

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

September 25, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations