Clinical trial

Hematoma Block vs. Bier Block: Which is More Effective for Closed Fracture Reduction?

Name
131997
Description
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.
Trial arms
Trial start
2021-07-15
Estimated PCD
2025-07-01
Trial end
2025-07-01
Phase
Early phase I
Treatment
Hematoma Local Anesthetic Block Procedure with 1% Lidocaine
Inject anesthetic into the hematoma site, 20 mL of 1% lidocaine without epinephrine.
Arms:
Hematoma Block
Other names:
Lignocaine, Xylocaine, Ztlido (lidocaine)
Bier Anesthetic Block Procedure with 1% Lidocaine
Intravenous anesthetic infusion, a maximum lidocaine dosing of 3 mg/kg.
Arms:
Bier Block
Other names:
Lignocaine, Xylocaine, Ztlido (lidocaine)
Size
500
Primary endpoint
Visual Analog Scale (VAS) pain
Prior to fracture manipulation
Visual Analog Scale (VAS) pain
During anesthetic injection or infusion, an average of 10 minutes.
Visual Analog Scale (VAS) pain
During fracture manipulation, an average of 10 minutes.
Visual Analog Scale (VAS) pain
30 minutes following fracture manipulation
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 500, 'type': 'ESTIMATED'}}
Updated at
2024-03-15

1 organization

2 products

1 indication

Organization
University of Utah
Product
Hematoma
Indication
Wrist Fractures