NCT02129270

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started May 2014

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2014

Completed
24 days until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 2, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

February 17, 2020

Status Verified

February 1, 2020

Enrollment Period

9 months

First QC Date

April 7, 2014

Last Update Submit

February 12, 2020

Conditions

Fractures of the Distal Radius

Keywords

Fractures of the distal radiusHematoma blockLidocaine

Outcome Measures

Primary Outcomes (1)

  • This study will be measured effective in terms of pain relieving with Visual Analog Scale.

    1 year

Secondary Outcomes (1)

  • This study will be measured safe in terms of complications to injection.

    1 year

Study Arms (2)

Lidocaine HCl 2%

ACTIVE COMPARATOR

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

Drug: Lidocaine HCl 2% .

Lidocaine HCl 1%

EXPERIMENTAL

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

Drug: Lidocaine HCl 1%

Interventions

Lidocaine HCl 2% .DRUG

comparison of different dosages of drug

Also known as: ESRACAIN
Lidocaine HCl 2%
Lidocaine HCl 1%DRUG

comparison of different dosages of drug

Also known as: ESRACAIN
Lidocaine HCl 1%

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with Fractures of the distal radius, with or without ulna fracture

You may not qualify if:

  • 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...)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HaEmek medical center

Afula, 18101, Israel

Location

Study Officials

  • Nimrod Rozen, Prof.

    HaEemek Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2014

First Posted

May 2, 2014

Study Start

May 1, 2014

Primary Completion

February 1, 2015

Study Completion

August 1, 2018

Last Updated

February 17, 2020

Record last verified: 2020-02

Locations

IL(1)