Local Anesthesia in Radial Catheterization (RAOLA)

Anesthetic Ointment vs Local Injectable Anesthetic in Trans-radial Cardiac Catheterization: The RAOLA Study

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.

Study Overview

• Status: Unknown
• Conditions: Coronary Artery Disease; Anesthesia, Local; Catheter Site Discomfort; Catheter Site Pain
• Intervention / Treatment: Drug: Local anesthetic; Drug: local anaesthetic injection

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.

• Study Type: Interventional
• Enrollment (Anticipated): 444
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: George Latsios, MD PhD; Email: glatsios@gmail.com

Study Locations

• Greece
  • Attiki
    • Athens, Attiki, Greece
      • Recruiting
      • Hippocration Hospital, Athens University Medical School
      • Contact: Dimitris Tousoulis, Ass. Professor; Phone Number: +30 210 7782446; Email: tousouli@med.uoa.gr
      • Principal Investigator: George Latsios, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Local anesthetic; Local skin anesthesia during radial coronary artery catheterization by EMLA anesthetic ointment; Other Names: Local anesthetic ointment
Active Comparator: 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	Drug: local anaesthetic injection; Local skin anesthesia during radial coronary artery catheterization by lidocaine injection; Other Names: Skin anethesia by lidocaine injection

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
Visual Analog Scale of Pain Perception 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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radial artery spasm	The occurrence of radial artery spasm in each group during radial artery catheterization	During radial artery catheterization
Puncture efficiency (number of puncture attempts)	The number of puncture attempts, the total time required before successful sheath insertion are documented in each group and constitute the secondary end points of the study.	During radial artery catheterization

Collaborators and Investigators

• Sponsor: Hippocration General Hospital
• Investigators: Study Director: Dimitris Tousoulis, MD PhD, Professor of Cardiology; Principal Investigator: George Latsios, MD PhD, Consultant Cardiologist

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2015
• Primary Completion (Anticipated): November 20, 2020
• Study Completion (Anticipated): January 10, 2021

Study Registration Dates

• First Submitted: February 24, 2017
• First Submitted That Met QC Criteria: March 1, 2017
• First Posted (Actual): March 7, 2017

Study Record Updates

• Last Update Posted (Actual): February 28, 2018
• Last Update Submitted That Met QC Criteria: February 26, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Membrane Transport Modulators; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Anesthetics; Lidocaine; Anesthetics, Local
• Other Study ID Numbers: HippocratioGH

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
• product manufactured in and exported from the U.S.: No