Anesthetic Ointment vs Local Injectable Anesthetic in Trans-radial Cardiac Catheterization: The RAOLA Study
Overview
- Phase
- Phase 4
- Intervention
- Local anesthetic
- Conditions
- Anesthesia, Local
- Sponsor
- Hippocration General Hospital
- Enrollment
- 444
- Locations
- 1
- Primary Endpoint
- Visual Analog Scale of Pain Perception during sheath insertion
- Last Updated
- 8 years ago
Overview
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.
Investigators
Dimitris Tousoulis
Professor of Cardiology
Hippocration General Hospital
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.
Arms & Interventions
EMLA anesthetic ointment (AO)
In AO group a layer of 2.5 gr EMLA cream (standard adult dose) is applied to both wrists, 1 cm above the styloid process of the radius 30 minutes before the puncture, by an experienced cathlab nurse.
Intervention: Local anesthetic
Local Skin Anesthetic Injection (LA)
In LA group the radial artery is infiltrated with 1-2 mL of 2% lidocaine, using a 26 G needle, 0.5-1 cm proximal to the styloid process one minute before the puncture
Intervention: local anaesthetic injection
Outcomes
Primary Outcomes
Visual Analog Scale of Pain Perception during sheath insertion
Time Frame: During artery puncture
The primary end-point of the study is the perception of radial pain assessed during artery puncture
Visual Analog Scale of Pain Perception after sheath removal
Time Frame: 30 minutes after sheath removal
The primary end-point of the study is the perception of radial pain assessed 30 minutes after sheath removal
Secondary Outcomes
- Puncture efficiency (number of puncture attempts)(During radial artery catheterization)
- Radial artery spasm(During radial artery catheterization)