RAOLA Observational: Local Anesthesia During Cardiac Catheterization

NCT03091049 | Completed

• 1 other identifier: RAOLA Observational
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

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

Conditions

Anesthesia, Local

Keywords

coronary; catheterization; transradial; anesthesia

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scale of Pain Perception during sheath insertion

  The primary end-point of the study is the perception of radial pain assessed during artery puncture

  During artery puncture

Secondary Outcomes (3)

• Puncture efficiency

  During radial artery catheterization

• Radial artery spasm

  During radial artery catheterization

• Visual Analog Scale of Pain Perception 30 minutes after sheath removal

  30 minutes after sheath removal

Study Arms (2)

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

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

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

A total of 800 consecutive patients, referred for elective coronary angiography In 1stCardiology Dpt Cath Lab with the suspicion of coronary artery disease (CAD) are enrolled in this study. All procedures will be undertaken by experienced and radial dedicated interventional cardiologists (i.e. more than 90% radial catheterizations). Exclusion criteria were 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

You may qualify if:

• \- patients, referred for elective diagnostic coronary angiography

You may not qualify if:

• 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

Sponsors & Collaborators

• Hippocration General Hospital: lead

Study Sites (1)

1st Cardiology Department Hippokration Hospital

Athens, Attica, 11528, Greece

Location

Study Officials

• Dimitris Tousoulis, MD PhD

  1st Cardiology Department - Athens Medical School

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Cardiology

Study Record Dates

• First Submitted: March 7, 2017
• First Posted: March 27, 2017
• Study Start: November 1, 2014
• Primary Completion: January 1, 2018
• Study Completion: January 10, 2018
• Last Updated: February 22, 2019

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)