Anesthesia, Local
Conditions
Keywords
coronary, catheterization, transradial, anesthesia
Brief summary
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
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.
Interventions
None listed
Sponsors
Hippocration General Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Puncture efficiency | 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 | 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 | 30 minutes after sheath removal | The primary end-point of the study is the perception of radial pain assessed 30 minutes after sheath removal |
Countries
Greece
Outcome results
None listed