NCT02346929

Brief Summary

The purpose of this study is to determine the efficacy of ultrasound guided hematoma block versus traditional "blind" hematoma block for analgesia in distal radius fracture reduction.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
115

participants targeted

Target at P50-P75 for not_applicable

Timeline
18mo left

Started Aug 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
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 Progress89%
Aug 2014Dec 2027

Study Start

First participant enrolled

August 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 27, 2015

Completed
12.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

March 3, 2026

Status Verified

March 1, 2026

Enrollment Period

13 years

First QC Date

January 13, 2015

Last Update Submit

March 2, 2026

Conditions

Distal Radius Fracture

Keywords

Hematoma blockdistal radius fracture reductionultrasoundultrasound guided hematoma blocktraditional hematoma block for analgesiabupivacainepain reductionwrist fracture

Outcome Measures

Primary Outcomes (1)

  • Pain Reduction as indicated by Visual Analog Scale

    Subjects will be surveyed on a Visual Analog Scale (VAS) on their pain during 4 points: prior to receiving hematoma block, after receiving hematoma block, during reduction and prior to discharge

    4 hours after initiation of study procedure

Study Arms (2)

ultrasound-guided hematoma block

EXPERIMENTAL

Patients in this arm will receive a bed-side ultrasound guided hematoma block with analgesia (0.25% bupivacaine)

Other: ultrasound guide

traditional hematoma block

NO INTERVENTION

Patients in this arm will have the hematoma block of the distal radius fracture with no ultrasound for guidance with analgesia (0.25% bupivacaine)

Interventions

ultrasound guideOTHER

Patients randomized to this arm will have the hematoma block of the distal radial fracture with the guidance of a bedside ultrasound

ultrasound-guided hematoma block

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patient ≥ 18 years old presenting to the emergency department with complaint of distal radius fracture

You may not qualify if:

  • High acuity/distress per the Attending ED physician
  • Altered mental status or intoxication
  • Aphasia, mental retardation, dementia, or insurmountable communication barrier
  • Acute psychiatric illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

Related Publications (8)

  • Furia JP, Alioto RJ, Marquardt JD. The efficacy and safety of the hematoma block for fracture reduction in closed, isolated fractures. Orthopedics. 1997 May;20(5):423-6. doi: 10.3928/0147-7447-19970501-11.

    PMID: 9172249BACKGROUND

  • Alioto RJ, Furia JP, Marquardt JD. Hematoma block for ankle fractures: a safe and efficacious technique for manipulations. J Orthop Trauma. 1995 Apr;9(2):113-6. doi: 10.1097/00005131-199504000-00004.

    PMID: 7776029BACKGROUND

  • Singh GK, Manglik RK, Lakhtakia PK, Singh A. Analgesia for the reduction of Colles fracture. A comparison of hematoma block and intravenous sedation. Online J Curr Clin Trials. 1992 Oct 1;Doc No 23:[3614 words; 43 paragraphs].

    PMID: 1343612BACKGROUND

  • Johnson PQ, Noffsinger MA. Hematoma block of distal forearm fractures. Is it safe? Orthop Rev. 1991 Nov;20(11):977-9.

    PMID: 1749663BACKGROUND

  • Walker KJ, McGrattan K, Aas-Eng K, Smith AF. Ultrasound guidance for peripheral nerve blockade. Cochrane Database Syst Rev. 2009 Oct 7;(4):CD006459. doi: 10.1002/14651858.CD006459.pub2.

    PMID: 19821368BACKGROUND

  • Atkinson P, Lennon R. Use of emergency department ultrasound in the diagnosis and early management of femoral fractures. Emerg Med J. 2003 Jul;20(4):395. doi: 10.1136/emj.20.4.395. No abstract available.

    PMID: 12835377BACKGROUND

  • Crystal CS, Miller MA, Young SE. Ultrasound guided hematoma block: a novel use of ultrasound in the traumatized patient. J Trauma. 2007 Feb;62(2):532-3. doi: 10.1097/01.ta.0000244398.89188.9c. No abstract available.

    PMID: 17297348BACKGROUND

  • Kiely PD, O'Farrell D, Riordan J, Harmon D. The use of ultrasound-guided hematoma blocks in wrist fractures. J Clin Anesth. 2009 Nov;21(7):540-2. doi: 10.1016/j.jclinane.2009.01.008. No abstract available.

    PMID: 20006267BACKGROUND

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and InjuriesFractures, Bone

Study Officials

  • Beatrice Hoffmann, MD

    Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Beatrice Hoffmann, MD

CONTACT

617-754-2323bhoffma2@bidmc.harvard.edu

Nathan I Shapiro, MD MPH

CONTACT

617-754-2332nshapiro@bidmc.harvard.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ED Faculty

Study Record Dates

First Submitted

January 13, 2015

First Posted

January 27, 2015

Study Start

August 1, 2014

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

March 3, 2026

Record last verified: 2026-03

Locations

US(1)