1st Cardiology Department Hippokration Hospital
Athens, Attica, 11528, Greece
NCT Number: NCT03091049
An open label observational clinical study to compare 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
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Notify Me18 year–90 year
All sexes
Observational
Athens, Attica, 11528, Greece
A total of 800 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 will be recorded.
The study will not involve any intervention but it will observe patients assigned to other EMLA cream or lidocaine injection for local anesthesia as part of their clinical routine treatment during transradial catherization.
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: During artery puncture
The primary end-point of the study is the perception of radial pain assessed during artery puncture
Time frame: During radial artery catheterization
The total time required for successful sheath insertion is documented in each group and constitutes the secondary end point of the study assessing puncture efficiency
Time frame: During radial artery catheterization
The occurrence of radial artery spasm in each group during radial artery catheterization
Time frame: 30 minutes after sheath removal
The primary end-point of the study is the perception of radial pain assessed 30 minutes after sheath removal
Hippocration General Hospital
Other
Trans-radial Cardiac Catheterization Local Anesthesia: an Observational Study
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