Coronary Artery Disease Clinical Trial
Official title:
Anesthetic Ointment vs Local Injectable Anesthetic in Trans-radial Cardiac Catheterization: The RAOLA Study
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.
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.
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