RAOLA Observational: Local Anesthesia During Cardiac Catheterization
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|ClinicalTrials.gov Identifier: NCT03091049|
Recruitment Status : Completed
First Posted : March 27, 2017
Last Update Posted : February 22, 2019
|Condition or disease|
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.
|Study Type :||Observational|
|Actual Enrollment :||800 participants|
|Official Title:||Trans-radial Cardiac Catheterization Local Anesthesia: an Observational Study|
|Actual Study Start Date :||November 1, 2014|
|Actual Primary Completion Date :||January 1, 2018|
|Actual Study Completion Date :||January 10, 2018|
EMLA anesthetic ointment (AO)
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)
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
- Visual Analog Scale of Pain Perception during sheath insertion [ Time Frame: During artery puncture ]The primary end-point of the study is the perception of radial pain assessed during artery puncture
- Puncture efficiency [ 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
- Radial artery spasm [ Time Frame: During radial artery catheterization ]The occurrence of radial artery spasm in each group during radial artery catheterization
- Visual Analog Scale of Pain Perception 30 minutes after sheath removal [ 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03091049
|1st Cardiology Department Hippokration Hospital|
|Athens, Attiki, Greece, 11528|
|Study Director:||Dimitris Tousoulis, MD PhD||1st Cardiology Department - Athens Medical School|