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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02857686
Other study ID # mini IVRA
Secondary ID
Status Not yet recruiting
Phase N/A
First received August 3, 2016
Last updated August 5, 2016
Start date October 2016
Est. completion date March 2017

Study information

Verified date August 2016
Source Cairo University
Contact Hassan Ali, lecturer
Phone 1001733687
Email hassan364@hotmail.com
Is FDA regulated No
Health authority Egypt: Ministry of Higher Education
Study type Interventional

Clinical Trial 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.


Description:

this study aimed at comparing IVRA with small dose lidocaine and forearm tourniquet with conventional IVRA with arm tourniquet and usual lidocaine dose


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date March 2017
Est. primary completion date January 2017
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
intravenous regional anaesthesia
tourniquet over the arm and intravenous lidocaine with a dose of 4 mg/kg
forearm IVRA
tourniquet over the forearm and lidocaine with a dose of 1.5 mg/ kg

Locations

Country Name City State
Egypt Cairo University Cairo Giza

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary pain visual analogue scale 2 hours Yes
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