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Local Anesthesia in Radial Catheterization — RAOLA  

Coronary Artery Disease Clinical Trial

Official title:
Anesthetic Ointment vs Local Injectable Anesthetic in Trans-radial Cardiac Catheterization: The RAOLA Study

Clinical Trial Summary

A randomized clinical trial to test the efficacy of EMLA cream (lidocaine 2.5% and prilocaine 2.5% in a ratio of 1:1 by weight) in comparison to the established local anesthesia (LA) protocol of lidocaine subcutaneous injection, in providing adequate peri-operative local anesthesia during transradial coronary angiography.

Clinical Trial Description

A total of 444 consecutive patients, who are referred for elective coronary angiography to 1st Cardiology Department cathlab, with the suspicion of coronary artery disease (CAD) will be enrolled in this study. Exclusion criteria are acute coronary syndrome, previous ipsilateral transradial approach, Raynaud's syndrome, abnormal renal function with or without need for hemodialysis, known history of sensitivity to local anesthetics, non-palpable radial pulse, abnormal Barbeau's test and patient's refusal. Baseline clinical, demographic and procedural data of the study population were recorded.

Participants will be randomly assigned to either the EMLA (AO) or the lidocaine group (LA), by a randomization table.

Primary end-point: the perception of radial pain assessed during artery puncture and 30 minutes after sheath removal.

Secondary end-point: The number of puncture attempts, the total time required before successful sheath insertion, and the occurrence of radial artery spasm will be also documented in each group

Participants will be observed for 4 hours post angiography for development of local complications or side effects. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03072394
Study type Interventional
Source Hippocration General Hospital
Contact George Latsios, MD PhD
Email glatsios@gmail.com
Status Recruiting
Phase Phase 4
Start date January 10, 2015
Completion date January 10, 2021
View Details
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