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Hematoma Block for Distal Radius Fracture (Hematoma Block)

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ClinicalTrials.gov Identifier: NCT02346929
Recruitment Status : Unknown
Verified July 2020 by Beatrice Hoffmann, Beth Israel Deaconess Medical Center.
Recruitment status was:  Recruiting
First Posted : January 27, 2015
Last Update Posted : October 22, 2020
Sponsor:
Collaborator:
Harvard University
Information provided by (Responsible Party):
Beatrice Hoffmann, Beth Israel Deaconess Medical Center

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.

Condition or disease Intervention/treatment Phase
Distal Radius Fracture Other: ultrasound guide Not Applicable

Detailed Description:

Hematoma blocks are safe and effective in providing analgesia for fracture reduction1-4. They involve injecting lidocaine directly into the fracture line for analgesia. The physician aspirates blood prior to injection to confirm placement in the hematoma created by the fracture. However, the procedure can be technically difficult if the fracture line is difficult to palpate, for example, due to significant swelling or body habitus. Ultrasound has been shown to improve efficacy in other analgesic procedures such as peripheral nerve blocks5 and also in identifying fracture lines6. There have been case reports and case series which have shown the feasibility and effectiveness of ultrasound guided hematoma blocks for analgesia in patients undergoing reduction for distal radius fractures7,8. To our knowledge there are no randomized controlled trials comparing the use of ultrasound guided hematoma blocks versus traditional hematoma blocks in achieving analgesia for distal radius fracture reduction.

In this study, we will determine if ultrasound improves the efficacy of analgesia when performing hematoma blocks for reduction of distal radius fractures.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 115 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Ultrasound-guided Hematoma Block and "Blind" Hematoma Block for Analgesia in Distal Radius Fractures
Actual Study Start Date : August 2014
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ultrasound-guided hematoma block
Patients in this arm will receive a bed-side ultrasound guided hematoma block with analgesia (0.25% bupivacaine)
Other: ultrasound guide
Patients randomized to this arm will have the hematoma block of the distal radial fracture with the guidance of a bedside ultrasound

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



Primary Outcome Measures :
  1. Pain Reduction as indicated by Visual Analog Scale [ Time Frame: 4 hours after initiation of study procedure ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02346929


Contacts
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Contact: Beatrice Hoffmann, MD 617-754-2323 bhoffma2@bidmc.harvard.edu
Contact: Nathan I Shapiro, MD MPH 617-754-2332 nshapiro@bidmc.harvard.edu

Locations
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United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Beatrice Hoffmann, MD    617-754-2323    bhoffma2@bidmc.harvard.edu   
Contact: Elinita Rosseto    617-754-2332    erosseto@bidmc.harvard.edu   
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Harvard University
Investigators
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Principal Investigator: Beatrice Hoffmann, MD Beth Israel Deaconess Medical Center
Publications:
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Responsible Party: Beatrice Hoffmann, ED Faculty, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT02346929    
Other Study ID Numbers: 2014P000173
First Posted: January 27, 2015    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: July 2020
Keywords provided by Beatrice Hoffmann, Beth Israel Deaconess Medical Center:
Hematoma block
distal radius fracture reduction
ultrasound
ultrasound guided hematoma block
traditional hematoma block for analgesia
bupivacaine
pain reduction
wrist fracture
Additional relevant MeSH terms:
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Hematoma
Fractures, Bone
Radius Fractures
Wounds and Injuries
Hemorrhage
Pathologic Processes
Forearm Injuries
Arm Injuries