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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EMLA anesthetic ointment (AO) | Experimental | 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) | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Local anesthetic | Drug | Local skin anesthesia during radial coronary artery catheterization by EMLA anesthetic ointment |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| George Latsios, MD PhD | Contact | glatsios@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Dimitris Tousoulis, MD PhD | Professor of Cardiology | Study Director |
| George Latsios, MD PhD | Consultant Cardiologist | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hippocration Hospital, Athens University Medical School | Recruiting | Athens | Attica | Greece |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000779 | Anesthetics, Local |
| D000772 | Anesthesia, Local |
| ID | Term |
|---|---|
| D000777 | Anesthetics |
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
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| local anaesthetic injection | Drug | Local skin anesthesia during radial coronary artery catheterization by lidocaine injection |
|
|
The occurrence of radial artery spasm in each group during radial artery catheterization |
| During radial artery catheterization |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D020164 | Chemical Actions and Uses |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |