Effect of Topical Anesthesia on Patient's Pain Discomfort and Radial Artery Spasm in Transradial Catheterization

Phase 4

• Conditions: Radial Artery Spasm
• Interventions: Drug: Topical Anesthetic; Drug: Placebo

• Registration Number: NCT03501212
• Lead Sponsor: Phramongkutklao College of Medicine and Hospital

Brief Summary

This study evaluate topical anaesthesia application for 30 minutes before tranradial catheterization during cardiac catheterization can reduce pain and decrease radial artery spasm

Detailed Description

The incidence of Radial artery spasm (RAS) has varied from 5-30% RAS refers to friction between the artery and wires or guide catheters accompanied by a subjective feeling of pain.

EMLA anesthetic ointment (AO-Astra Zeneca) is an emulsion of lidocaine 2.5% and prilocaine 2.5% in a ratio of 1:1 by weight Previous study showed that EMLA cream can increase the success rate of femoral cannulation in children.

Study Timeline

• Study First Submitted: 2018-03-21
• Study First Submitted QC: 2018-04-16
• Study First Posted: 2018-04-18
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-28
• Last Update Posted: 2018-08-29
• Study Start: 2019-04-27
• Primary Completion: 2019-06-27
• Study Completion: 2019-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Patients age >18 years.
• Patients who was schedule to performed coronary angiogram

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Exclusion Criteria

Previous ipsilateral transradial approach Raynaud's syndrome ESRD History of sensitivity to local anesthetics Non-palpable redial pulse Abnormal Barbeau's test Local site infection Patient's refusal

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interventional	Topical Anesthetic	EMLA group layer of 2.5 gr EMLA cream (standard adult dose) was applied to both wrists
Placebo	Placebo	Placebo cream was applied to both wrists

Primary Outcome Measures

Name	Time	Method
Radial pain assessed during artery puncture	30 min	Record pain by visual analog score sub-scale 0(no pain)-10(max pain)

Secondary Outcome Measures

Name	Time	Method
Occurrence of radial artery spasm	during and post procedure up to 1 years	NuNumber of radial artery spasm
Radial pain assessed 30 min after sheath removal	4 hr post procedure	Record pain by visual analog score
Number of puncture attempts	imediate post procedure	Number of puncture attempts

Trial Locations

Locations (1)

Department of Internal Medicine; 🇹🇭 Bangkok, Thailand