RAOLA Observational: Local Anesthesia During Cardiac Catheterization

NCT ID: NCT03091049

Last Updated: 2019-02-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 800 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-11-01
• Study Completion Date: 2018-01-10

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.

Conditions

Anesthesia, Local

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hippocration General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dimitris Tousoulis

Professor of Cardiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dimitris Tousoulis, MD PhD

Role: STUDY_DIRECTOR

1st Cardiology Department - Athens Medical School

Locations

1st Cardiology Department Hippokration Hospital

Athens, Attica, Greece

Countries

Greece

Other Identifiers

RAOLA Observational

Identifier Type: -

Identifier Source: org_study_id