Fractures of the Distal Radius Clinical Trial
Official title:
Phase 4 Study of Hematoma Block for Reduction of Distal Radius Fractures
| NCT number | NCT02129270 |
| Other study ID # | 158-13-EMC |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 4 |
| First received | |
| Last updated | |
| Start date | May 2014 |
| Est. completion date | August 2018 |
| Verified date | February 2020 |
| Source | HaEmek Medical Center, Israel |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 24 |
| Est. completion date | August 2018 |
| Est. primary completion date | February 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 15 Years and older |
| Eligibility |
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...) |
| Country | Name | City | State |
|---|---|---|---|
| Israel | HaEmek medical center | Afula |
| Lead Sponsor | Collaborator |
|---|---|
| HaEmek Medical Center, Israel |
Israel,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | This study will be measured effective in terms of pain relieving with Visual Analog Scale. | 1 year | ||
| Secondary | 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. | 1 year |