Ultrasound Guided Hematoma Block in Distal Forearm Fractures

Sponsor

State University of New York - Upstate Medical University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05537831

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Forearm Fracture	Device: Ultrasound	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

96 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Pain relief from landmark versus ultrasound guided hematoma block [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

7 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

State University of New York - Upstate Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Paul Klawitter, Associate Profressor, State University of New York - Upstate Medical University

ClinicalTrials.gov Identifier:

NCT05537831

Other Study ID Numbers:

1954614

First Posted:

Sep 13, 2022

Last Update Posted:

Sep 13, 2022

Last Verified:

Sep 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Paul Klawitter, Associate Profressor, State University of New York - Upstate Medical University

Ultrasound

Hematoma block

Additional relevant MeSH terms:

Hematoma

Fractures, Bone

Study Results

No Results Posted as of Sep 13, 2022