Anesthesia, Local, Coronary Artery Disease, Catheter Site Discomfort, Catheter Site Pain
Conditions
Brief summary
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
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.
Interventions
DRUGLocal anesthetic
Local skin anesthesia during radial coronary artery catheterization by EMLA anesthetic ointment
Local skin anesthesia during radial coronary artery catheterization by lidocaine injection
Sponsors
Hippocration General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale of Pain Perception during sheath insertion | During artery puncture | The primary end-point of the study is the perception of radial pain assessed during artery puncture |
| Visual Analog Scale of Pain Perception after sheath removal | 30 minutes after sheath removal | The primary end-point of the study is the perception of radial pain assessed 30 minutes after sheath removal |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Puncture efficiency (number of puncture attempts) | During radial artery catheterization | 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. |
| Radial artery spasm | During radial artery catheterization | The occurrence of radial artery spasm in each group during radial artery catheterization |
Countries
Greece
Contacts
Primary ContactGeorge Latsios, MD PhD
Outcome results
None listed