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 range18 Years – 80 Years
SexALL
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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.
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