RAOLA Observational: Local Anesthesia During Cardiac Catheterization

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Trans-radial Cardiac Catheterization Local Anesthesia: an Observational Study

Conditions
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Anesthesia, Local

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - patients, referred for elective diagnostic coronary angiography Exclusion Criteria: 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 patient's refusal

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| EMLA anesthetic ointment (AO)<br>In AO group a layer of 2.5 gr EMLA cream (standard adult dose) is applied to both wrists, 1 cm above the styloid process of the radius 30 minutes before the puncture, by an experienced cathlab nurse | |
| Local Skin Anesthetic Injection (LA)<br>In LA group the radial artery is infiltrated with 1-2 mL of 2% lidocaine, using a 26 G needle, 0.5-1 cm proximal to the styloid process one minute before the puncture | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual 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 | During artery puncture | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Puncture efficiency | 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 | During radial artery catheterization | 
| Radial artery spasm | The occurrence of radial artery spasm in each group during radial artery catheterization | During radial artery catheterization | 
| Visual Analog Scale of Pain Perception 30 minutes after sheath removal | The primary end-point of the study is the perception of radial pain assessed 30 minutes after sheath removal | 30 minutes after sheath removal | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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coronary, catheterization, transradial, anesthesia