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RAOLA Observational: Local Anesthesia During Cardiac Catheterization

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ClinicalTrials.gov Identifier: NCT03091049
Recruitment Status : Completed
First Posted : March 27, 2017
Last Update Posted : February 22, 2019
Sponsor:
Information provided by (Responsible Party):
Dimitris Tousoulis, Hippocration General Hospital

Brief Summary:
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

Condition or disease
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.


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Study Type : Observational
Actual Enrollment : 800 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Trans-radial Cardiac Catheterization Local Anesthesia: an Observational Study
Actual Study Start Date : November 1, 2014
Actual Primary Completion Date : January 1, 2018
Actual Study Completion Date : January 10, 2018

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



Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03091049


Locations
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Greece
1st Cardiology Department Hippokration Hospital
Athens, Attiki, Greece, 11528
Sponsors and Collaborators
Hippocration General Hospital
Investigators
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Study Director: Dimitris Tousoulis, MD PhD 1st Cardiology Department - Athens Medical School

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Responsible Party: Dimitris Tousoulis, Professor of Cardiology, Hippocration General Hospital
ClinicalTrials.gov Identifier: NCT03091049     History of Changes
Other Study ID Numbers: RAOLA Observational
First Posted: March 27, 2017    Key Record Dates
Last Update Posted: February 22, 2019
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dimitris Tousoulis, Hippocration General Hospital:
coronary
catheterization
transradial
anesthesia
Additional relevant MeSH terms:
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Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs