Local Anesthesia in Radial Catheterization

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Anesthesia, Local, Coronary Artery Disease, Catheter Site Discomfort, Catheter Site Pain

Intervention / Treatment
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* Drug: Local anesthetic
* Drug: local anaesthetic injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: referral 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 and 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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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 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. | Drug: Local anesthetic<br>* Local skin anesthesia during radial coronary artery catheterization by EMLA anesthetic ointment<br>* Other names: Local anesthetic ointment;|
| Active Comparator: 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 | Drug: local anaesthetic injection<br>* Local skin anesthesia during radial coronary artery catheterization by lidocaine injection<br>* Other names: Skin anethesia by lidocaine injection;|

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 | 
| 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 | 30 minutes after sheath removal | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | During radial artery catheterization | 
| Radial artery spasm | The occurrence of radial artery spasm in each group during radial artery catheterization | During radial artery catheterization |