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CompletedNCT02129270Updated Feb 17, 2020

Hematoma Block for Reduction of Distal Radius Fractures

A Phase 4 interventional study of Lidocaine HCl 2% . and Lidocaine HCl 1% in Fractures of the Distal Radius, sponsored by HaEmek Medical Center, Israel. Completed at 1 site in Israel. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2020-02-17.

Sponsored by HaEmek Medical Center, Israel · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
15 Years and older
Sex
All
01

Study summary

The purpose of this study is to Prove that injection of 15 to 20 mL of lidocaine 1% into the fracture site (Hematoma block) is more effective in terms of pain relieving then injection of 10 mL of lidocaine 2%, and equally safe in terms of complications, for closed reduction of distal radius fractures.

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Conditions studied

  • Fractures of the Distal Radius

Keywords

  • Fractures of the distal radius
  • Hematoma block
  • Lidocaine
03

In context

Lead sponsor

HaEmek Medical Center, Israel is the lead sponsor of 237 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients with Fractures of the distal radius, with or without ulna fracture

Exclusion criteria

Exclusion Criteria:

  • Children,
  • pregnant women,
  • patients with infection or suspected infection on the site for injection.
  • Patients whose condition requires general anesthesia (patients with more fractures other than the distal radius and ulna, patients with many damage...)
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Active comparator
    Lidocaine HCl 2%

    Lidocaine HCl 2% (200mg/10ml) 10 ml.

    Drug: Lidocaine HCl 2% .

  • Experimental
    Lidocaine HCl 1%

    Lidocaine HCl 1% (100mg/10ml) 15-20 ml.

    Drug: Lidocaine HCl 1%

Interventions

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What researchers measure

Primary outcomes

  1. This study will be measured effective in terms of pain relieving with Visual Analog Scale.

    Time frame: 1 year

Secondary outcomes

  1. This study will be measured safe in terms of complications to injection.

    Number of Participants with Adverse Events as a Measure of Safety and Tolerability.

    Time frame: 1 year

07

Study locations

1 site
  • HaEmek medical center
    Afula, 18101, Israel
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 17, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02129270
Responsible party
Sponsor
First posted
May 2, 2014
Start date
May 2014
Primary completion
Feb 2015
Completion
Aug 2018
Last update
Feb 17, 2020

Study contacts

Nimrod Rozen, Prof.
principal investigator · HaEemek Medical Center
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Lidocaine

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