Forearm FractureNCT05537831
Ultrasound Guided Hematoma Block in Distal Forearm Fractures
A study testing Ultrasound in people with Forearm Fracture, run by State University of New York - Upstate Medical University.
Trial summary
This is a randomized control trial comparing the efficacy of ultrasound (US) guided vs landmark-guided hematoma blocks on distal forearm fractures. Read more about this study
- Who is it for?
- Ages 7 years and older
- Conditions the study is for
- Forearm Fracture
- What is being tested?
- Ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- Sep 2022to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Prisoners
- Pregnant women
- Patients with altered mental status/have impaired decision-making capacity.
- Patients with allergies to amide anesthetics
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
- Conditions
- Forearm Fracture
- Being tested
- Ultrasound
- Keywords
- Ultrasound, Hematoma block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDevice
The ultrasound will be used to assist with the delivery of a hematoma block in patients with distal forearm fractures.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change in pain score from before the hematoma block to immediately after the reduction/splinting of the forearm fracture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2022
- Study startSep 2022 (estimated)
- Primary completionSep 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Forearm FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- State University of New York - Upstate Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul Klawitter, State University of New York - Upstate Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05537831
- Sponsor's protocol ID
- 1954614
- Status last verified
- Sep 2022
- First submitted
- 2 Sep 2022
- Last updated
- 13 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided vs Landmark-based Hematoma Block in Distal Forearm Fractures
- ClinicalTrials.gov ID
- NCT05537831
- Acronym / sponsor ID
- 1954614
- Conditions
- Forearm Fracture
- Keywords
- Ultrasound, Hematoma block
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- State University of New York - Upstate Medical UniversityUniversity, hospital or other
- Study start
- Sep 2022 (estimated)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 13 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized control trial comparing the efficacy of ultrasound (US) guided vs landmark-guided hematoma blocks on distal forearm fractures.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Intervention Group (Ultrasound) | Active comparator | Device: UltrasoundThe 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. |
| 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. |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Prisoners
- Pregnant women
- Patients with altered mental status/have impaired decision-making capacity.
- Patients with allergies to amide anesthetics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UltrasoundThe ultrasound will be used to assist with the delivery of a hematoma block in patients with distal forearm fractures. | Device | Study Intervention Group (Ultrasound) |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound in people with Forearm Fracture, run by State University of New York - Upstate Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paul Klawitter, MD (315-464-8691, klawittp@upstate.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2022.