Ultrasound Guided Hematoma Block in Distal Forearm Fractures

NCT05537831 | Unknown

• 1 other identifier: 1954614
• Study Type: interventional
• Target: 96
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Forearm Fracture

Keywords

Ultrasound; Hematoma block

Outcome Measures

Primary Outcomes (1)

• 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.

  Change in pain score from before the hematoma block to immediately after the reduction/splinting of the forearm fracture

Study Arms (2)

Study Intervention Group (Ultrasound)

ACTIVE COMPARATOR

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

Study Control Group (Landmark)

NO INTERVENTION

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.

Interventions

Ultrasound DEVICE

The ultrasound will be used to assist with the delivery of a hematoma block in patients with distal forearm fractures.

Study Intervention Group (Ultrasound)

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• State University of New York - Upstate Medical University: lead

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Paul Klawitter, MD

CONTACT

315-464-8691; klawittp@upstate.edu

Jerome Hoke, MD

CONTACT

315-464-4363; hokej@upstate.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Profressor

Study Record Dates

• First Submitted: September 2, 2022
• First Posted: September 13, 2022
• Study Start: September 1, 2022
• Primary Completion: September 1, 2023
• Study Completion: December 1, 2023
• Last Updated: September 13, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share