NCT02129270CompletedPhase 4
Phase 4 Study of Hematoma Block for Reduction of Distal Radius Fractures
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- This study will be measured effective in terms of pain relieving with Visual Analog Scale.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 15 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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...)
Arms & Interventions
Lidocaine HCl 2%
Active Comparator
Lidocaine HCl 2% (200mg/10ml) 10 ml.
Intervention: Lidocaine HCl 2% . (Drug)
Lidocaine HCl 1%
Experimental
Lidocaine HCl 1% (100mg/10ml) 15-20 ml.
Intervention: Lidocaine HCl 1% (Drug)
Outcomes
Primary Outcomes
This study will be measured effective in terms of pain relieving with Visual Analog Scale.
Time Frame: 1 year
Secondary Outcomes
- This study will be measured safe in terms of complications to injection.(1 year)
Investigators
Study Sites (1)
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