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Hematoma Block for Reduction of Distal Radius Fractures

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ClinicalTrials.gov Identifier: NCT02129270
Recruitment Status : Unknown
Verified April 2014 by HaEmek Medical Center, Israel.
Recruitment status was:  Not yet recruiting
First Posted : May 2, 2014
Last Update Posted : May 2, 2014
Sponsor:
Information provided by (Responsible Party):
HaEmek Medical Center, Israel

Brief 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.

Condition or disease Intervention/treatment Phase
Fractures of the Distal Radius Drug: Lidocaine HCl 2% . Drug: Lidocaine HCl 1% Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 4 Study of Hematoma Block for Reduction of Distal Radius Fractures
Study Start Date : May 2014
Estimated Primary Completion Date : February 2015

Resource links provided by the National Library of Medicine


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 Name: ESRACAIN

Experimental: Lidocaine HCl 1%
Lidocaine HCl 1% (100mg/10ml) 15-20 ml.
Drug: Lidocaine HCl 1%
comparison of different dosages of drug
Other Name: ESRACAIN




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

Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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...)

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): NCT02129270


Contacts
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Contact: Chagay Orbach, Dr +972525343174 chagayor1@gmail.com

Locations
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Israel
HaEmek medical center Not yet recruiting
Afula, Israel, 18101
Contact: Chagay Orbach, Dr       chagayor1@gmail.com   
Sub-Investigator: Chagay Orbach, Dr         
Sponsors and Collaborators
HaEmek Medical Center, Israel
Investigators
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Principal Investigator: Nimrod Rozen, Prof. HaEemek Medical Center

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Responsible Party: HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT02129270     History of Changes
Other Study ID Numbers: 158-13-EMC
First Posted: May 2, 2014    Key Record Dates
Last Update Posted: May 2, 2014
Last Verified: April 2014

Keywords provided by HaEmek Medical Center, Israel:
Fractures of the distal radius
Hematoma block
Lidocaine

Additional relevant MeSH terms:
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Fractures, Bone
Radius Fractures
Hematoma
Wounds and Injuries
Forearm Injuries
Arm Injuries
Hemorrhage
Pathologic Processes
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action