Hematoma Block for Reduction of Distal Radius Fractures

NCT ID: NCT02129270

Last Updated: 2020-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2018-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Fractures of the Distal Radius

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lidocaine HCl 2%

Lidocaine HCl 2% (200mg/10ml) 10 ml.

Group Type ACTIVE_COMPARATOR

Lidocaine HCl 2% .

Intervention Type DRUG

comparison of different dosages of drug

Lidocaine HCl 1%

Lidocaine HCl 1% (100mg/10ml) 15-20 ml.

Group Type EXPERIMENTAL

Lidocaine HCl 1%

Intervention Type DRUG

comparison of different dosages of drug

Interventions

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Lidocaine HCl 2% .

comparison of different dosages of drug

Intervention Type DRUG

Lidocaine HCl 1%

comparison of different dosages of drug

Intervention Type DRUG

Other Intervention Names

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ESRACAIN ESRACAIN

Eligibility Criteria

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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...)
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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HaEmek Medical Center, Israel

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nimrod Rozen, Prof.

Role: PRINCIPAL_INVESTIGATOR

HaEemek Medical Center

Locations

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HaEmek medical center

Afula, , Israel

Site Status

Countries

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Israel

Other Identifiers

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158-13-EMC

Identifier Type: -

Identifier Source: org_study_id

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