PENG vs. FIC Blocks in Hip Fractures in the ED

March 21, 2024 updated by: Orange Park Medical Center

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

This study is a prospective, randomized clinical trial assessing the efficacy of physician-performed ultrasound-guided pericapsular nerve group (PENG) block vs fascia iliaca compartment (FIC) block for pain control in acute hip fracture.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult (>= 18 years of age)
  • Isolated proximal hip fracture (defined as Intertrochanteric or more proximal) as identified by X-ray, Computed Tomography (CT) scan or Magnetic Resonance Imaging (MRI) scan
  • Glasgow Coma Score (GCS) = 15
  • Subjective pain score of >= 5 on a scale of 0 to 10 just prior to the nerve block placement

Exclusion Criteria:

  • Patients who are unable to give consent due to altered mental status or dementia
  • Clinically intoxicated patients
  • Patients who are unable to communicate their numeric level of pain
  • Open fracture or penetrating hip trauma
  • Signs of infection or laceration at injection site
  • Patients with multi-system trauma
  • Painful distracting injury (injury causing significant pain that distracts the patient from having reliable scoring of hip fracture pain, e.g. humerus fracture, dislocated joint)
  • Requiring immediate surgical intervention (< 1 hour)
  • Deemed clinically unstable by treating physician
  • Abnormal vital signs (Pulse>120bpm, Systolic blood pressure < 100 mm Hg, Pulse O2 < 95%)
  • Patients on long-acting systemic opioid analgesia
  • Allergy to amide local anesthetics
  • Vulnerable populations including pregnant patients, prisoners, children, elderly dementia patients. All precautions will be taken to avoid coercion, harm and exploitation of these vulnerable populations, thus they are to be excluded from this study. They will receive pain medications as deemed appropriate by their treating physician.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pericapsular Nerve Group (PENG) Block
Procedure: Pericapsular Nerve Group (PENG) Block

Under sterile technique, physician will identify relevant landmarks including the femoral artery, femoral vein, femoral nerve, ileopubic eminence (IPE), anterior inferior iliac spine (AIIS), psoas tendon (PT). Target area is bony space between AIIS and IPE adjacent to PT.

Using in-plane technique with constant visualization, needle will be inserted through skin and soft tissue targeting fascial plane below the psoas tendon, above ilium bone. Landmark lies between the AIIS and IPE, just lateral to psoas tendon.

As needle tip reaches target, small volume of normal saline will be injected to hydrodissect tissue. Fluid will start to spread along fascial plane, lifting the psoas tendon from ilium, confirming proper positioning.

Normal saline will then be switched to anesthetic (30mL of Bupivacaine 0.25%).

After full volume of anesthetic has been injected, a small volume (5mL) of normal saline will be injected to flush line of remaining anesthetic. Needle will then be withdrawn.
Experimental: Fascia Iliaca Compartment (FIC) Block
Procedure: Fascia Iliaca Compartment (FIC) Block for Patients with Isolated Hip Fractures

Under sterile technique, physician will identify relevant landmarks, including femoral artery, femoral vein, femoral nerve, iliacus muscle with overlying fascia iliaca.

Using in-plane technique with constant visualization, needle will be inserted through skin and soft tissue targeting the fascial plane above iliacus muscle.

As needle tip reaches the target, a small volume of normal saline will be injected to hydrodissect tissue. Fluid will start to spread along fascial plane, confirming proper positioning.

Normal saline will then be switched to anesthetic (30mL of Bupivacaine 0.25%).

After full volume of anesthetic has been injected, a small volume (5mL) of normal saline will be injected to flush the line of remaining anesthetic. The needle will then be withdrawn.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Numeric pain score at 30 minutes
Time Frame: 30 minutes after block placement
30 minutes after block placement
Numeric pain score at 60 minutes
Time Frame: 1 hour after block placement
1 hour after block placement

Secondary Outcome Measures

Outcome Measure
Time Frame
Cumulative Morphine Milligram Equivalents in 24 hours after enrollment
Time Frame: 24 hours after enrollment
24 hours after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Orange Park Medical Center

Investigators

  • Principal Investigator: Taryn Hoffman, MD, HCA Florida Orange Park Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

March 21, 2024

First Submitted That Met QC Criteria

March 21, 2024

First Posted (Actual)

March 28, 2024

Study Record Updates

Last Update Posted (Actual)

March 28, 2024

Last Update Submitted That Met QC Criteria

March 21, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-537

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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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