NCT02857686

Brief Summary

The safety and effectiveness of the "mini-dose" Bier block, a technique of i.v. regional anesthesia using low-dose lidocaine (1.5 mg/kg) without routine premedication, was evaluated in the emergency department treatment of pediatric upper extremity fractures and dislocations.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 3, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 5, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

August 9, 2016

Status Verified

August 1, 2016

Enrollment Period

3 months

First QC Date

August 3, 2016

Last Update Submit

August 5, 2016

Conditions

Local Anaesthesia

Outcome Measures

Primary Outcomes (1)

  • pain

    visual analogue scale

    2 hours

Study Arms (2)

arm intravenous regional anesthesia

ACTIVE COMPARATOR

tourniquet over the arm and intravenous lidocaine with a dose of 4 mg/kg

Procedure: intravenous regional anaesthesia

forearm intravenous regional anesthesia

EXPERIMENTAL

tourniquet over the forearm and lidocaine with a dose of 1.5 mg/ kg

Procedure: forearm IVRA

Interventions

intravenous regional anaesthesiaPROCEDURE

tourniquet over the arm and intravenous lidocaine with a dose of 4 mg/kg

arm intravenous regional anesthesia
forearm IVRAPROCEDURE

tourniquet over the forearm and lidocaine with a dose of 1.5 mg/ kg

forearm intravenous regional anesthesia

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA(American society of anesthesia) I, II , consent, forearm or arm surgery

You may not qualify if:

  • ASA(American society of anesthesia) III or more, allergy, refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, Giza Governorate, 1234, Egypt

Location

Central Study Contacts

Hassan Ali, lecturer

CONTACT

1001733687hassan364@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer in anesthesia department Cairo university

Study Record Dates

First Submitted

August 3, 2016

First Posted

August 5, 2016

Study Start

October 1, 2016

Primary Completion

January 1, 2017

Study Completion

March 1, 2017

Last Updated

August 9, 2016

Record last verified: 2016-08

Locations

EG(1)