RAOLA Observational: Local Anesthesia During Cardiac Catheterization

Completed

• Conditions: Anesthesia, Local

• Registration Number: NCT03091049
• Lead Sponsor: Hippocration General Hospital

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.

Study Timeline

• Study Start: 2014-11-01
• Study First Submitted: 2017-03-07
• Study First Submitted QC: 2017-03-21
• Study First Posted: 2017-03-27
• Primary Completion: 2018-01-01
• Study Completion: 2018-01-10
• Status Verified: 2018-02
• Last Update Submitted: 2019-02-21
• Last Update Posted: 2019-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 800

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale of Pain Perception during sheath insertion	During artery puncture	The primary end-point of the study is the perception of radial pain assessed during artery puncture

Secondary Outcome Measures

Name	Time	Method
Puncture efficiency	During radial artery catheterization	The total time required for successful sheath insertion is documented in each group and constitutes the secondary end point of the study assessing puncture efficiency
Radial artery spasm	During radial artery catheterization	The occurrence of radial artery spasm in each group during radial artery catheterization
Visual Analog Scale of Pain Perception 30 minutes after sheath removal	30 minutes after sheath removal	The primary end-point of the study is the perception of radial pain assessed 30 minutes after sheath removal

Trial Locations

Locations (1)

1st Cardiology Department Hippokration Hospital; 🇬🇷 Athens, Attiki, Greece