Hematoma Block for Distal Radius Fracture (Hematoma Block)
Primary Purpose
Distal Radius Fracture
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ultrasound guide
Sponsored by
About this trial
This is an interventional treatment trial for Distal Radius Fracture focused on measuring Hematoma block, distal radius fracture reduction, ultrasound, ultrasound guided hematoma block, traditional hematoma block for analgesia, bupivacaine, pain reduction, wrist fracture
Eligibility 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
Sites / Locations
- Beth Israel Deaconess Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
ultrasound-guided hematoma block
traditional hematoma block
Arm Description
Patients in this arm will receive a bed-side ultrasound guided hematoma block with analgesia (0.25% bupivacaine)
Patients in this arm will have the hematoma block of the distal radius fracture with no ultrasound for guidance with analgesia (0.25% bupivacaine)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT02346929
First Posted
January 13, 2015
Last Updated
October 19, 2020
Sponsor
Beth Israel Deaconess Medical Center
Collaborators
Harvard University
1. Study Identification
Unique Protocol Identification Number
NCT02346929
Brief Title
Hematoma Block for Distal Radius Fracture
Acronym
Hematoma Block
Official Title
Comparison of Ultrasound-guided Hematoma Block and "Blind" Hematoma Block for Analgesia in Distal Radius Fractures
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 2014 (Actual)
Primary Completion Date
August 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center
Collaborators
Harvard University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distal Radius Fracture
Keywords
Hematoma block, distal radius fracture reduction, ultrasound, ultrasound guided hematoma block, traditional hematoma block for analgesia, bupivacaine, pain reduction, wrist fracture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
115 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ultrasound-guided hematoma block
Arm Type
Experimental
Arm Description
Patients in this arm will receive a bed-side ultrasound guided hematoma block with analgesia (0.25% bupivacaine)
Arm Title
traditional hematoma block
Arm Type
No Intervention
Arm Description
Patients in this arm will have the hematoma block of the distal radius fracture with no ultrasound for guidance with analgesia (0.25% bupivacaine)
Intervention Type
Other
Intervention Name(s)
ultrasound guide
Intervention Description
Patients randomized to this arm will have the hematoma block of the distal radial fracture with the guidance of a bedside ultrasound
Primary Outcome Measure Information:
Title
Pain Reduction as indicated by Visual Analog Scale
Description
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
Time Frame
4 hours after initiation of study procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Beatrice Hoffmann, MD
Phone
617-754-2323
Email
bhoffma2@bidmc.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Nathan I Shapiro, MD MPH
Phone
617-754-2332
Email
nshapiro@bidmc.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beatrice Hoffmann, MD
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Beatrice Hoffmann, MD
Phone
617-754-2323
Email
bhoffma2@bidmc.harvard.edu
First Name & Middle Initial & Last Name & Degree
Elinita Rosseto
Phone
617-754-2332
Email
erosseto@bidmc.harvard.edu
12. IPD Sharing Statement
Citations:
PubMed Identifier
9172249
Citation
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.
Results Reference
background
PubMed Identifier
7776029
Citation
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.
Results Reference
background
PubMed Identifier
1343612
Citation
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].
Results Reference
background
PubMed Identifier
1749663
Citation
Johnson PQ, Noffsinger MA. Hematoma block of distal forearm fractures. Is it safe? Orthop Rev. 1991 Nov;20(11):977-9.
Results Reference
background
PubMed Identifier
19821368
Citation
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.
Results Reference
background
PubMed Identifier
12835377
Citation
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.
Results Reference
background
PubMed Identifier
17297348
Citation
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.
Results Reference
background
PubMed Identifier
20006267
Citation
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.
Results Reference
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Hematoma Block for Distal Radius Fracture
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