Local Anesthesia in Radial Catheterization

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

444 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-10

Study Completion Date

2021-01-10

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Local anesthetic

Intervention Type DRUG

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

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

Group Type ACTIVE_COMPARATOR

local anaesthetic injection

Intervention Type DRUG

Local skin anesthesia during radial coronary artery catheterization by lidocaine injection

Interventions

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Local anesthetic

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

Intervention Type DRUG

local anaesthetic injection

Local skin anesthesia during radial coronary artery catheterization by lidocaine injection

Intervention Type DRUG

Other Intervention Names

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Local anesthetic ointment Skin anethesia by lidocaine injection

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No