Clinical trial NCT03091049: RAOLA Observational: Local Anesthesia During Cardiac Catheterization
Official title: Trans-radial Cardiac Catheterization Local Anesthesia: an Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia, Local
Keywords: coronary
catheterization
transradial
anesthesia
Lead sponsor: Hippocration General Hospital
Sponsor class: OTHER
First posted: 2017-03-27
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A total of 800 consecutive patients, referred for elective coronary angiography In 1stCardiology Dpt Cath Lab with the suspicion of coronary artery disease (CAD) are enrolled in this study. All procedures will be undertaken by experienced and radial dedicated interventional cardiologists (i.e. more than 90% radial catheterizations). Exclusion criteria were 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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Visual Analog Scale of Pain Perception during sheath insertion
timeFrame: During artery puncture
Secondary outcomes:
measure: Puncture efficiency
timeFrame: During radial artery catheterization
measure: Radial artery spasm
timeFrame: During radial artery catheterization
measure: Visual Analog Scale of Pain Perception 30 minutes after sheath removal
timeFrame: 30 minutes after sheath removal
Other outcomes:
Locations:
city: Athens
country: Greece
facility: 1st Cardiology Department Hippokration Hospital
state: Attiki
Study officials:
affiliation: 1st Cardiology Department - Athens Medical School
name: Dimitris Tousoulis, MD PhD
role: STUDY_DIRECTOR
References: