Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2026-01-04 @ 3:58 PM
Study NCT ID:
NCT03072394
Status:
UNKNOWN
Last Update Posted:
2018-02-28
First Post:
2017-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Local Anesthesia in Radial Catheterization
Sponsor:
Hippocration General Hospital
Organization:
Study Overview
Official Title:
Anesthetic Ointment vs Local Injectable Anesthetic in Trans-radial Cardiac Catheterization: The RAOLA Study
Status:
UNKNOWN
Status Verified Date:
2018-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RAOLA
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: