Ultrasound Guided Hematoma Block in Distal Forearm Fractures

September 9, 2022 updated by: Paul Klawitter, State University of New York - Upstate Medical University

Ultrasound Guided vs Landmark-based Hematoma Block in Distal Forearm Fractures

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

96

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

Study Contact Backup

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

7 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Study Intervention Group (Ultrasound)
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.
Device: Ultrasound
The ultrasound will be used to assist with the delivery of a hematoma block in patients with distal forearm fractures.
NO_INTERVENTION: Study Control Group (Landmark)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain relief from landmark versus ultrasound guided hematoma block
Time Frame: Change in pain score from before the hematoma block to immediately after the reduction/splinting of the forearm fracture
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.
Change in pain score from before the hematoma block to immediately after the reduction/splinting of the forearm fracture

Collaborators and Investigators

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

Sponsor

State University of New York - Upstate Medical University

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 (ANTICIPATED)

September 1, 2022

Primary Completion (ANTICIPATED)

September 1, 2023

Study Completion (ANTICIPATED)

December 1, 2023

Study Registration Dates

First Submitted

September 2, 2022

First Submitted That Met QC Criteria

September 9, 2022

First Posted (ACTUAL)

September 13, 2022

Study Record Updates

Last Update Posted (ACTUAL)

September 13, 2022

Last Update Submitted That Met QC Criteria

September 9, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1954614

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

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.

Clinical Trials on Forearm Fracture

Clinical Trials on Ultrasound

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Vietnam

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe