Hematoma Block Versus Bier Block for Closed Fracture Reduction (NCT05086224) | Clinical Trial Compass
Active — Not RecruitingEarly Phase 1
Hematoma Block Versus Bier Block for Closed Fracture Reduction
United States500 participantsStarted 2021-07-15
Plain-language summary
The investigators objective of this study is to evaluate the effectiveness of hematoma block versus intravenous regional anesthesia (Bier block) during closed reduction of distal radius fractures.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adults (age 18+ years of age) with a closed distal radius.
* Eligible patients will be those who require a closed reduction for a displaced fracture.
* Any distal radius that falls outside of normal anatomic parameters will require reduction.
* Normal anatomic parameters include radial inclination: 22°; mean, 19° to 29°, radial height: 11 to 12 mm, and volar tilt 11°; mean,11° to 14.5°.
* Patients presenting with intact neurovascular exam will be included (sensation intact about ulnar, median, and radial nerve distributions with an intact radial pulse.
Exclusion Criteria:
* Not able to provide informed consent (intubated or cognitively impaired).
* Member of vulnerable populations such as non-English speaking and incarcerated patients.
* Pregnant or lactating women.
* Have open fractures or altered neurovascular exams.
* Have any confounding injures such as an associated dislocation or subluxation of the carpus or patients who have a concomitant upper extremity injury requiring surgery.
* Patients who will obtain follow-up elsewhere (as they will not be able to be studied longitudinally.
* Patients who have are unable to tolerate the tourniquet pressure while awake or in whom IV access is unable to be obtained in the correct hand will be excluded from the bier block arm of the study.
* Patients with skin compromise or breakdown or active infection overlying fracture site will be excluded from the hematoma block arm.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Visual Analog Scale (VAS) pain
Timeframe: Prior to fracture manipulation
2
Visual Analog Scale (VAS) pain
Timeframe: During anesthetic injection or infusion, an average of 10 minutes.
3
Visual Analog Scale (VAS) pain
Timeframe: During fracture manipulation, an average of 10 minutes.
4
Visual Analog Scale (VAS) pain
Timeframe: 30 minutes following fracture manipulation