RAOLA Observational: Local Anesthesia During Cardiac Catheterization

Trans-radial Cardiac Catheterization Local Anesthesia: an Observational Study

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

Study Overview

• Status: Completed
• Conditions: Anesthesia, Local

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 Type: Observational
• Enrollment (Actual): 800

Contacts and Locations

Study Locations

• Greece
  • Attiki
    • Athens, Attiki, Greece, 11528
      • 1st Cardiology Department Hippokration Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Puncture efficiency	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	During radial artery catheterization
Radial artery spasm	The occurrence of radial artery spasm in each group during radial artery catheterization	During radial artery catheterization
Visual Analog Scale of Pain Perception 30 minutes after sheath removal	The primary end-point of the study is the perception of radial pain assessed 30 minutes after sheath removal	30 minutes after sheath removal

Collaborators and Investigators

• Sponsor: Hippocration General Hospital
• Investigators: Study Director: Dimitris Tousoulis, MD PhD, 1st Cardiology Department - Athens Medical School

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2014
• Primary Completion (Actual): January 1, 2018
• Study Completion (Actual): January 10, 2018

Study Registration Dates

• First Submitted: March 7, 2017
• First Submitted That Met QC Criteria: March 21, 2017
• First Posted (Actual): March 27, 2017

Study Record Updates

• Last Update Posted (Actual): February 22, 2019
• Last Update Submitted That Met QC Criteria: February 21, 2019
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: anesthesia; transradial; coronary; catheterization
• Other Study ID Numbers: RAOLA Observational

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No