Back to resultsHematoma Block for Reduction of Distal Radius Fractures
Primary Purpose
Fractures of the Distal Radius
Status
Completed
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
Lidocaine HCl 2% .
Lidocaine HCl 1%
Sponsored by
About this trial
This is an interventional treatment trial for Fractures of the Distal Radius focused on measuring Fractures of the distal radius, Hematoma block, Lidocaine
Eligibility 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...)
Sites / Locations
- HaEmek medical center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Lidocaine HCl 2%
Lidocaine HCl 1%
Arm Description
Lidocaine HCl 2% (200mg/10ml) 10 ml.
Lidocaine HCl 1% (100mg/10ml) 15-20 ml.
Outcomes
Primary Outcome Measures
This study will be measured effective in terms of pain relieving with Visual Analog Scale.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02129270
First Posted
April 7, 2014
Last Updated
February 12, 2020
Sponsor
HaEmek Medical Center, Israel
1. Study Identification
Unique Protocol Identification Number
NCT02129270
Brief Title
Hematoma Block for Reduction of Distal Radius Fractures
Official Title
Phase 4 Study of Hematoma Block for Reduction of Distal Radius Fractures
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
May 2014 (Actual)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
August 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HaEmek Medical Center, Israel
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fractures of the Distal Radius
Keywords
Fractures of the distal radius, Hematoma block, Lidocaine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lidocaine HCl 2%
Arm Type
Active Comparator
Arm Description
Lidocaine HCl 2% (200mg/10ml) 10 ml.
Arm Title
Lidocaine HCl 1%
Arm Type
Experimental
Arm Description
Lidocaine HCl 1% (100mg/10ml) 15-20 ml.
Intervention Type
Drug
Intervention Name(s)
Lidocaine HCl 2% .
Other Intervention Name(s)
ESRACAIN
Intervention Description
comparison of different dosages of drug
Intervention Type
Drug
Intervention Name(s)
Lidocaine HCl 1%
Other Intervention Name(s)
ESRACAIN
Intervention Description
comparison of different dosages of drug
Primary Outcome Measure Information:
Title
This study will be measured effective in terms of pain relieving with Visual Analog Scale.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
This study will be measured safe in terms of complications to injection.
Description
Number of Participants with Adverse Events as a Measure of Safety and Tolerability.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility 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...)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nimrod Rozen, Prof.
Organizational Affiliation
HaEemek Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
HaEmek medical center
City
Afula
ZIP/Postal Code
18101
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Hematoma Block for Reduction of Distal Radius Fractures
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