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Recruiting NCT02346929

Hematoma Block for Distal Radius Fracture

No phase Interventional Distal Radius Fracture

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ultrasound guide.
Who it may be relevant to
Registry conditions: Distal Radius Fracture. Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Comparison of Ultrasound-guided Hematoma Block and "Blind" Hematoma Block for Analgesia in Distal Radius Fractures

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Pain Reduction as indicated by Visual Analog Scale [Time frame: 4 hours after initiation of study procedure]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Beth Israel Deaconess Medical Center — Boston

Publications

  • 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 9172249
  • 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 7776029
  • 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 1343612
  • Johnson PQ, Noffsinger MA. Hematoma block of distal forearm fractures. Is it safe? Orthop Rev. 1991 Nov;20(11):977-9. PMID 1749663
  • 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 19821368
  • 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 12835377
  • 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 17297348
  • 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 20006267

Identifiers

NCT: NCT02346929 · 2014P000173

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗