Local Anesthesia in Radial Catheterization

NCT03072394 | Unknown Phase 4

• 1 other identifier: HippocratioGH
• Study Type: interventional
• Target: 444
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anesthesia, Local; Coronary Artery Disease; Catheter Site Discomfort; Catheter Site Pain

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Puncture efficiency (number of puncture attempts)

  During radial artery catheterization

• Radial artery spasm

  During radial artery catheterization

Study Arms (2)

EMLA anesthetic ointment (AO)

EXPERIMENTAL

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 Anesthetic Injection (LA)

ACTIVE COMPARATOR

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

Interventions

Local anesthetic DRUG

Local skin anesthesia during radial coronary artery catheterization by EMLA anesthetic ointment

Also known as: Local anesthetic ointment

EMLA anesthetic ointment (AO)

local anaesthetic injection DRUG

Local skin anesthesia during radial coronary artery catheterization by lidocaine injection

Also known as: Skin anethesia by lidocaine injection

Local Skin Anesthetic Injection (LA)

Eligibility Criteria

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

You may qualify if:

• referral 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 and patient's refusal.

Sponsors & Collaborators

• Hippocration General Hospital: lead

Study Sites (1)

Hippocration Hospital, Athens University Medical School

Athens, Attica, Greece

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Anesthetics, Local; Anesthesia, Local

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses; Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• Dimitris Tousoulis, MD PhD

  Professor of Cardiology

  STUDY DIRECTOR

• George Latsios, MD PhD

  Consultant Cardiologist

  PRINCIPAL INVESTIGATOR

Central Study Contacts

George Latsios, MD PhD

CONTACT

glatsios@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Cardiology

Study Record Dates

• First Submitted: February 24, 2017
• First Posted: March 7, 2017
• Study Start: January 10, 2015
• Primary Completion: November 20, 2020
• Study Completion: January 10, 2021
• Last Updated: February 28, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)