Hematoma Block for Reduction of Distal Radius Fractures

February 12, 2020 updated by: HaEmek Medical Center, Israel

Phase 4 Study of Hematoma Block for Reduction of Distal Radius Fractures

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Afula, Israel, 18101
        • Haemek Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

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...)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Lidocaine HCl 2%
Lidocaine HCl 2% (200mg/10ml) 10 ml.
Drug: Lidocaine HCl 2% .
comparison of different dosages of drug
Other Names:
  • ESRACAIN
Experimental: Lidocaine HCl 1%
Lidocaine HCl 1% (100mg/10ml) 15-20 ml.
Drug: Lidocaine HCl 1%
comparison of different dosages of drug
Other Names:
  • ESRACAIN

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
This study will be measured effective in terms of pain relieving with Visual Analog Scale.
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
This study will be measured safe in terms of complications to injection.
Time Frame: 1 year
Number of Participants with Adverse Events as a Measure of Safety and Tolerability.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HaEmek Medical Center, Israel

Investigators

  • Principal Investigator: Nimrod Rozen, Prof., HaEemek Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2014

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

August 1, 2018

Study Registration Dates

First Submitted

April 7, 2014

First Submitted That Met QC Criteria

April 30, 2014

First Posted (Estimate)

May 2, 2014

Study Record Updates

Last Update Posted (Actual)

February 17, 2020

Last Update Submitted That Met QC Criteria

February 12, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 158-13-EMC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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