Forearm FractureNCT00775554
Comparison Study of Using Ultrasound Guidance for Hematoma Blocks vs. Traditional Approach
A study testing ultrasound guided hematoma block in people with Forearm Fracture, run by St. Luke's-Roosevelt Hospital Center at 1 site in United States.
Trial summary
Will use visual analog scales to compare effectiveness of traditional hematoma block vs ultrasound guided hematoma block with regards to pain. This will be done for closed forearm fractures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Forearm Fracture
- What is being tested?
- ultrasound guided hematoma block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Aug 2009
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18
- Closed forearm fracture
Who cannot join
- Mentally impaired, visually impaired or deaf
- Age < 18
- Alcohol on board
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Luke's Roosevelt Hospital
New York, New York, 10025
About this study
Official title: "Are Ultrasound-guided Hematoma Blocks for Distal Forearm Fractures Superior to the Landmark-guided Method for Hematoma Blocks?"
Will use visual analog scales to compare effectiveness of traditional hematoma block vs ultrasound guided hematoma block with regards to pain. This will be done for closed forearm fractures.
- Conditions
- Forearm Fracture
- Being tested
- ultrasound guided hematoma block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound guided hematoma blockOther
Also called ultrasound
pt. will receive ultrasound guided hematoma block
ultrasound guided hematoma blockOther
Also called ultrasound
ultrasound will be used to guide hematoma blocks
| Study group | Role | What they receive |
|---|---|---|
| traditional hematoma block | Other | people will receive traditional hematoma block for closed forearm fractures Receives: Other: ultrasound guided hematoma block |
| ultrasound guided hematoma block | Other | pts. will receive a hematoma block using bedside ultrasound to guide the placement Receives: Other: ultrasound guided hematoma block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog scale movement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2008 (estimated)
- Study startSep 2008
- Primary completionAug 2009 (estimated)
Why it stopped: no participants enrolled
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
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Luke's-Roosevelt Hospital Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00775554
- Sponsor's protocol ID
- 08-118
- Status last verified
- Oct 2008
- First submitted
- 17 Oct 2008
- Last updated
- 14 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Are Ultrasound-guided Hematoma Blocks for Distal Forearm Fractures Superior to the Landmark-guided Method for Hematoma Blocks?"
- ClinicalTrials.gov ID
- NCT00775554
- Acronym / sponsor ID
- 08-118
- Conditions
- Forearm Fracture
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- St. Luke's-Roosevelt Hospital CenterUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Aug 2009 (estimated)
- First posted
- 20 Oct 2008 (estimated)
- 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.
Will use visual analog scales to compare effectiveness of traditional hematoma block vs ultrasound guided hematoma block with regards to pain. This will be done for closed forearm fractures.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| traditional hematoma block | Other | Other: ultrasound guided hematoma blockpeople will receive traditional hematoma block for closed forearm fractures |
| ultrasound guided hematoma block | Other | Other: ultrasound guided hematoma blockpts. will receive a hematoma block using bedside ultrasound to guide the placement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age > 18
- Closed forearm fracture
Key exclusion criteria (3 listed)
- Mentally impaired, visually impaired or deaf
- Age < 18
- Alcohol on board
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 |
|---|---|---|
| ultrasound guided hematoma blockAlso: ultrasoundpt. will receive ultrasound guided hematoma block | Other | traditional hematoma block |
| ultrasound guided hematoma blockAlso: ultrasoundultrasound will be used to guide hematoma blocks | Other | ultrasound guided hematoma block |
Primary outcome
Visual analog scale movement
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound guided hematoma block in people with Forearm Fracture, run by St. Luke's-Roosevelt Hospital Center at 1 site in United States.
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 2 inclusion and 3 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: withdrawn, as of the sponsor's last update on 14 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analog scale movement. 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 14 Oct 2015.