NCT05086224

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for early_phase_1

Timeline
14mo left

Started Jul 2021

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress81%
Jul 2021Jul 2027

Study Start

First participant enrolled

July 15, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 16, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 20, 2021

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

April 23, 2026

Status Verified

April 1, 2026

Enrollment Period

6 years

First QC Date

September 16, 2021

Last Update Submit

April 21, 2026

Conditions

Distal Radius Fractures

Keywords

Distal radius fracturesHematoma blockBier blockPain

Outcome Measures

Primary Outcomes (4)

  • Visual Analog Scale (VAS) pain

    VAS pain score (0 no pain - 10 severe pain)

    Prior to fracture manipulation

  • Visual Analog Scale (VAS) pain

    VAS pain score (0 no pain - 10 severe pain)

    During anesthetic injection or infusion, an average of 10 minutes.

  • Visual Analog Scale (VAS) pain

    VAS pain score (0 no pain - 10 severe pain)

    During fracture manipulation, an average of 10 minutes.

  • Visual Analog Scale (VAS) pain

    VAS pain score (0 no pain - 10 severe pain)

    30 minutes following fracture manipulation

Study Arms (2)

Hematoma Block

OTHER

Inject 20 mL of 1% lidocaine without epinephrine into the hematoma site.

Drug: Hematoma Local Anesthetic Block Procedure with 1% Lidocaine

Bier Block

OTHER

Intravenous administration a maximum lidocaine dose of 3 mg/kg.

Drug: Bier Anesthetic Block Procedure with 1% Lidocaine

Interventions

Hematoma Local Anesthetic Block Procedure with 1% LidocaineDRUG

Inject anesthetic into the hematoma site, 20 mL of 1% lidocaine without epinephrine.

Also known as: Lignocaine, Xylocaine, Ztlido (lidocaine)
Hematoma Block
Bier Anesthetic Block Procedure with 1% LidocaineDRUG

Intravenous anesthetic infusion, a maximum lidocaine dosing of 3 mg/kg.

Also known as: Lignocaine, Xylocaine, Ztlido (lidocaine)
Bier Block

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah Orthopaedic Center

Salt Lake City, Utah, 84108, United States

Location

MeSH Terms

Conditions

Wrist FracturesPain

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and InjuriesFractures, BoneNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Lucas Marchand, MD

    University of Utah Orthopaedics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

September 16, 2021

First Posted

October 20, 2021

Study Start

July 15, 2021

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

April 23, 2026

Record last verified: 2026-04

Locations

US(1)