RAOLA Observational: Local Anesthesia During Cardiac Catheterization

Anesthesia, Local Clinical Trial

Official title:

Trans-radial Cardiac Catheterization Local Anesthesia: an Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03091049
• Other study ID #: RAOLA Observational
• Status: Completed
• Start date: November 1, 2014
• Est. completion date: January 10, 2018

Study information

• Verified date: February 2018
• Source: Hippocration General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

An open label observational clinical study to compare 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

Description:

A total of 800 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 will be recorded.

The study will not involve any intervention but it will observe patients assigned to other EMLA cream or lidocaine injection for local anesthesia as part of their clinical routine treatment during transradial catherization.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 800
• Est. completion date: January 10, 2018
• Est. primary completion date: January 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• patients, referred 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

• patient's refusal

Related Conditions & MeSH terms

• Anesthesia, Local

Locations

Country	Name	City	State
Greece	1st Cardiology Department Hippokration Hospital	Athens	Attiki

Sponsors (1)

Lead Sponsor	Collaborator
Hippocration General Hospital

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Scale of Pain Perception during sheath insertion	The primary end-point of the study is the perception of radial pain assessed during artery puncture	During artery puncture
Secondary	Puncture efficiency	The total time required for successful sheath insertion is documented in each group and constitutes the secondary end point of the study assessing puncture efficiency	During radial artery catheterization
Secondary	Radial artery spasm	The occurrence of radial artery spasm in each group during radial artery catheterization	During radial artery catheterization
Secondary	Visual Analog Scale of Pain Perception 30 minutes after sheath removal	The primary end-point of the study is the perception of radial pain assessed 30 minutes after sheath removal	30 minutes after sheath removal