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OpenTrials
Completed

NCT Number: NCT03091049

RAOLA Observational: Local Anesthesia During Cardiac Catheterization

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

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Key information

Conditions

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

1st Cardiology Department Hippokration Hospital

Athens, Attica, 11528, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. Puncture efficiency

    Time frame: During radial artery catheterization

    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

  2. Radial artery spasm

    Time frame: During radial artery catheterization

    The occurrence of radial artery spasm in each group during radial artery catheterization

  3. Visual Analog Scale of Pain Perception 30 minutes 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

Sponsors and collaborators

Lead sponsor

Hippocration General Hospital

Other

Registry information

Official study title

Trans-radial Cardiac Catheterization Local Anesthesia: an Observational Study

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Mar 27, 2017
Registry last updated
Feb 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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