Local Anesthesia in Radial Catheterization

Phase 4

• Conditions: Anesthesia, Local; Catheter Site Discomfort; Coronary Artery Disease; Catheter Site Pain
• Interventions: Drug: Local anesthetic; Drug: local anaesthetic injection

• Registration Number: NCT03072394
• Lead Sponsor: Hippocration General Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2015-01-10
• Study First Submitted: 2017-02-24
• Study First Submitted QC: 2017-03-01
• Study First Posted: 2017-03-07
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-26
• Last Update Posted: 2018-02-28
• Primary Completion: 2020-11-20
• Study Completion: 2021-01-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 444

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EMLA anesthetic ointment (AO)	Local anesthetic	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)	local anaesthetic injection	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

Name	Time	Method
Visual Analog Scale of Pain Perception during sheath insertion	During artery puncture	The primary end-point of the study is the perception of radial pain assessed during artery puncture
Visual Analog Scale of Pain Perception after sheath removal	30 minutes after sheath removal	The primary end-point of the study is the perception of radial pain assessed 30 minutes after sheath removal

Secondary Outcome Measures

Name	Time	Method
Puncture efficiency (number of puncture attempts)	During radial artery catheterization	The number of puncture attempts, the total time required before successful sheath insertion are documented in each group and constitute the secondary end points of the study.
Radial artery spasm	During radial artery catheterization	The occurrence of radial artery spasm in each group during radial artery catheterization

Trial Locations

Locations (1)

Hippocration Hospital, Athens University Medical School; 🇬🇷 Athens, Attiki, Greece