Clinical trial NCT03072394: Local Anesthesia in Radial Catheterization
Official title: Anesthetic Ointment vs Local Injectable Anesthetic in Trans-radial Cardiac Catheterization: The RAOLA Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Anesthesia, Local
Coronary Artery Disease
Catheter Site Discomfort
Catheter Site Pain
Lead sponsor: Hippocration General Hospital
Sponsor class: OTHER
First posted: 2017-03-07
Enrollment: 444
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Visual Analog Scale of Pain Perception during sheath insertion
timeFrame: During artery puncture
measure: Visual Analog Scale of Pain Perception after sheath removal
timeFrame: 30 minutes after sheath removal
Secondary outcomes:
measure: Puncture efficiency (number of puncture attempts)
timeFrame: During radial artery catheterization
measure: Radial artery spasm
timeFrame: During radial artery catheterization
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Hippocration Hospital, Athens University Medical School
state: Attiki
Study officials:
affiliation: Professor of Cardiology
name: Dimitris Tousoulis, MD PhD
role: STUDY_DIRECTOR
affiliation: Consultant Cardiologist
name: George Latsios, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: