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Ultrasound Guided Hematoma Block in Distal Forearm Fractures

Primary Purpose

Forearm Fracture

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ultrasound
Sponsored by
State University of New York - Upstate Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Forearm Fracture focused on measuring Ultrasound, Hematoma block

Eligibility Criteria

7 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients greater than and equal to seven years of age
  • Patients with traumatic acute distal radius/ulnar fractures with displacement that require reduction and immobilization with splinting
  • Patients that receive distal radius hematoma blocks, including those who require additional pain control adjuncts if pain control is not adequate

Exclusion Criteria:

  • Prisoners
  • Pregnant women
  • Patients with altered mental status/have impaired decision-making capacity.
  • Patients with allergies to amide anesthetics

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    Study Intervention Group (Ultrasound)

    Study Control Group (Landmark)

    Arm Description

    The ultrasound probe will be used for real-time needle and hematoma localization using the linear probe. The hematoma block will then be performed with aseptic technique. The skin will be prepped with chlorhexidine. A 20-gauge needle will be inserted in-plane into the hematoma site. A small amount of blood will be aspirated to confirm placement and 5-10 mL of 1% lidocaine will be infiltrated.

    The ultrasound probe will be in place on the patient's arm to maintain single blinding of the study. The ultrasound machine will not be used for needle and hematoma localization. The hematoma block will then be performed with aseptic technique. The skin will be prepped with chlorhexidine. A 20-gauge needle will be inserted in-plane into the hematoma site. A small amount of blood will be aspirated to confirm placement and 5-10 mL of 1% lidocaine will be infiltrated.

    Outcomes

    Primary Outcome Measures

    Pain relief from landmark versus ultrasound guided hematoma block
    Pain will be measured using a ten point Likert scale with zero designated as no pain and ten being the worst pain the patient can imagine. The higher score the worse the outcome.

    Secondary Outcome Measures

    Full Information

    First Posted
    September 2, 2022
    Last Updated
    September 9, 2022
    Sponsor
    State University of New York - Upstate Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05537831
    Brief Title
    Ultrasound Guided Hematoma Block in Distal Forearm Fractures
    Official Title
    Ultrasound Guided vs Landmark-based Hematoma Block in Distal Forearm Fractures
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2022 (Anticipated)
    Primary Completion Date
    September 2023 (Anticipated)
    Study Completion Date
    December 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    State University of New York - Upstate Medical University

    4. Oversight

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

    5. Study Description

    Brief Summary
    This is a randomized control trial comparing the efficacy of ultrasound (US) guided vs landmark-guided hematoma blocks on distal forearm fractures.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Forearm Fracture
    Keywords
    Ultrasound, Hematoma block

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    96 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Study Intervention Group (Ultrasound)
    Arm Type
    Active Comparator
    Arm Description
    The ultrasound probe will be used for real-time needle and hematoma localization using the linear probe. The hematoma block will then be performed with aseptic technique. The skin will be prepped with chlorhexidine. A 20-gauge needle will be inserted in-plane into the hematoma site. A small amount of blood will be aspirated to confirm placement and 5-10 mL of 1% lidocaine will be infiltrated.
    Arm Title
    Study Control Group (Landmark)
    Arm Type
    No Intervention
    Arm Description
    The ultrasound probe will be in place on the patient's arm to maintain single blinding of the study. The ultrasound machine will not be used for needle and hematoma localization. The hematoma block will then be performed with aseptic technique. The skin will be prepped with chlorhexidine. A 20-gauge needle will be inserted in-plane into the hematoma site. A small amount of blood will be aspirated to confirm placement and 5-10 mL of 1% lidocaine will be infiltrated.
    Intervention Type
    Device
    Intervention Name(s)
    Ultrasound
    Intervention Description
    The ultrasound will be used to assist with the delivery of a hematoma block in patients with distal forearm fractures.
    Primary Outcome Measure Information:
    Title
    Pain relief from landmark versus ultrasound guided hematoma block
    Description
    Pain will be measured using a ten point Likert scale with zero designated as no pain and ten being the worst pain the patient can imagine. The higher score the worse the outcome.
    Time Frame
    Change in pain score from before the hematoma block to immediately after the reduction/splinting of the forearm fracture

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    7 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients greater than and equal to seven years of age Patients with traumatic acute distal radius/ulnar fractures with displacement that require reduction and immobilization with splinting Patients that receive distal radius hematoma blocks, including those who require additional pain control adjuncts if pain control is not adequate Exclusion Criteria: Prisoners Pregnant women Patients with altered mental status/have impaired decision-making capacity. Patients with allergies to amide anesthetics
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Paul Klawitter, MD
    Phone
    315-464-8691
    Email
    klawittp@upstate.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jerome Hoke, MD
    Phone
    315-464-4363
    Email
    hokej@upstate.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Ultrasound Guided Hematoma Block in Distal Forearm Fractures

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