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

Radial Artery Spasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03501212
• Other study ID #: PMK-2018
• Status: Recruiting
• Phase: Phase 4
• Start date: April 27, 2019
• Est. completion date: June 30, 2019

Study information

• Verified date: August 2018
• Source: Phramongkutklao College of Medicine and Hospital
• Contact: Anuwat Rintaravitoon
• Phone: +66869920022
• Email: Rintaravitoon[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 30, 2019
• Est. primary completion date: June 27, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients age >18 years.

• Patients who was schedule to performed coronary angiogram

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

Related Conditions & MeSH terms

• Peripheral Vascular Diseases
• Radial Artery Spasm
• Spasm

Intervention

Drug:
• Topical Anesthetic
EMLA Cream 2.5 gr applied to both wrists
• Placebo
Placebo Cream 2.5gr applied to both wrist

Locations

Country	Name	City	State
Thailand	Department of Internal Medicine	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Phramongkutklao College of Medicine and Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radial pain assessed during artery puncture	Record pain by visual analog score sub-scale 0(no pain)-10(max pain)	30 min
Secondary	Radial pain assessed 30 min after sheath removal	Record pain by visual analog score	4 hr post procedure
Secondary	Number of puncture attempts	Number of puncture attempts	imediate post procedure
Secondary	Occurrence of radial artery spasm	NuNumber of radial artery spasm	during and post procedure up to 1 years