Ultrasound Guided Hematoma Block in Distal Forearm Fractures

NCT ID: NCT05537831

Last Updated: 2022-09-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-30
• Study Completion Date: 2023-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Ultrasound

Intervention Type: DEVICE

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

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Ultrasound

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

State University of New York - Upstate Medical University

OTHER

Sponsor Role: lead

Responsible Party

Paul Klawitter

Associate Profressor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Paul Klawitter, MD

Role: CONTACT

klawittp@upstate.edu

315-464-8691

Jerome Hoke, MD

Role: CONTACT

hokej@upstate.edu

315-464-4363

Other Identifiers

1954614

Identifier Type: -

Identifier Source: org_study_id