NCT03072394

Local Anesthesia in Radial Catheterization

Anesthetic Ointment vs Local Injectable Anesthetic in Trans-radial Cardiac Catheterization: The RAOLA Study

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 444 (estimated)
• Sponsor: Hippocration General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Anesthesia, Local
• Coronary Artery Disease
• Catheter Site Discomfort
• Catheter Site Pain

Interventions

Type	Name	Description
DRUG	Local anesthetic	Local skin anesthesia during radial coronary artery catheterization by EMLA anesthetic ointment
DRUG	local anaesthetic injection	Local skin anesthesia during radial coronary artery catheterization by lidocaine injection

Timeline

• Start date: 2015-01-10
• Primary completion: 2020-11-20
• Completion: 2021-01-10
• First posted: 2017-03-07
• Last updated: 2018-02-28

Locations

1 site across 1 country: Greece