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

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

Study Overview

• Status: Unknown
• Conditions: Radial Artery Spasm
• Intervention / Treatment: Drug: Topical Anesthetic; Drug: Placebo

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 Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Anuwat Rintaravitoon; Phone Number: +66869920022; Email: Rintaravitoon@hotmail.com
• Study Contact Backup: Name: Nakarin Sansanatudh; Phone Number: +666444755

Study Locations

• Thailand
  • Bangkok, Thailand, 10400
    • Recruiting
    • Department of Internal Medicine
    • Contact: Nakarin Sansanayudh, MD,PhD; Phone Number: 93827 +6623547600; Email: dr_nakarin@hotmail.com
    • Contact: Anuwat Rintaravitoon, MD; Phone Number: 33334 +66869920022; Email: Rintaravitoon@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Interventional; EMLA group layer of 2.5 gr EMLA cream (standard adult dose) was applied to both wrists	Drug: Topical Anesthetic; EMLA Cream 2.5 gr applied to both wrists
Placebo Comparator: Placebo; Placebo cream was applied to both wrists	Drug: Placebo; Placebo Cream 2.5gr applied to both wrist

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radial pain assessed during artery puncture	Record pain by visual analog score sub-scale 0(no pain)-10(max pain)	30 min

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Phramongkutklao College of Medicine and Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): April 27, 2019
• Primary Completion (Anticipated): June 27, 2019
• Study Completion (Anticipated): June 30, 2019

Study Registration Dates

• First Submitted: March 21, 2018
• First Submitted That Met QC Criteria: April 16, 2018
• First Posted (Actual): April 18, 2018

Study Record Updates

• Last Update Posted (Actual): August 29, 2018
• Last Update Submitted That Met QC Criteria: August 28, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Peripheral Vascular Diseases; Spasm; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local
• Other Study ID Numbers: PMK-2018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No