Local Anesthesia in Radial Catheterization

Overview

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.

Full Title of Study: “Anesthetic Ointment vs Local Injectable Anesthetic in Trans-radial Cardiac Catheterization: The RAOLA Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Single (Investigator)
  • Study Primary Completion Date: November 20, 2020

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.

Interventions

  • Drug: Local anesthetic
    • Local skin anesthesia during radial coronary artery catheterization by EMLA anesthetic ointment
  • Drug: local anaesthetic injection
    • Local skin anesthesia during radial coronary artery catheterization by lidocaine injection

Arms, Groups and Cohorts

  • 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.
  • 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

Clinical Trial Outcome Measures

Primary Measures

  • Visual Analog Scale of Pain Perception during sheath insertion
    • Time Frame: During artery puncture
    • The primary end-point of the study is the perception of radial pain assessed during artery puncture
  • Visual Analog Scale of Pain Perception after sheath removal
    • Time Frame: 30 minutes after sheath removal
    • The primary end-point of the study is the perception of radial pain assessed 30 minutes after sheath removal

Secondary Measures

  • Puncture efficiency (number of puncture attempts)
    • Time Frame: During radial artery catheterization
    • 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.
  • Radial artery spasm
    • Time Frame: During radial artery catheterization
    • The occurrence of radial artery spasm in each group during radial artery catheterization

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hippocration General Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dimitris Tousoulis, Professor of Cardiology – Hippocration General Hospital
  • Overall Official(s)
    • Dimitris Tousoulis, MD PhD, Study Director, Professor of Cardiology
    • George Latsios, MD PhD, Principal Investigator, Consultant Cardiologist
  • Overall Contact(s)
    • George Latsios, MD PhD, glatsios@gmail.com

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