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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
444
Local skin anesthesia during radial coronary artery catheterization by EMLA anesthetic ointment
Local skin anesthesia during radial coronary artery catheterization by lidocaine injection
Hippocration Hospital, Athens University Medical School
Athens, Attica, Greece
RECRUITINGVisual Analog Scale of Pain Perception during sheath insertion
The primary end-point of the study is the perception of radial pain assessed during artery puncture
Time frame: During artery puncture
Visual Analog Scale of Pain Perception after sheath removal
The primary end-point of the study is the perception of radial pain assessed 30 minutes after sheath removal
Time frame: 30 minutes after sheath removal
Puncture efficiency (number of puncture attempts)
The number of puncture attempts, the total time required before successful sheath insertion are documented in each group and constitute the secondary end points of the study.
Time frame: During radial artery catheterization
Radial artery spasm
The occurrence of radial artery spasm in each group during radial artery catheterization
Time frame: During radial artery catheterization
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