Safety/Efficacy Study of Local Anesthetic Prior to Femoral Artery Sheath Removal - Tabular View

Tracking Information

First Received Date ^ICMJE

April 23, 2007

Last Updated Date

August 21, 2008

Start Date ^ICMJE

May 2007

Primary Completion Date

September 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Incidence of vasovagal reaction during femoral sheath removal [ Time Frame: During sheath removal ] [ Designated as safety issue: No ]
Pain intensity during femoral sheath removal [ Time Frame: During sheath removal ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Incidence of vasovagal reaction during femoral sheath removal
Pain intensity during femoral sheath removal

Change History

Complete list of historical versions of study NCT00465439 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Safety/Efficacy Study of Local Anesthetic Prior to Femoral Artery Sheath Removal

Official Title ^ICMJE

Randomized Controlled Trial Examining the Effect of Subcutaneous Xylocaine 2% on the Incidence of Vasovagal Reactions and Pain Intensity During Femoral Artery Sheath Removal.

Brief Summary

This randomized controlled trial will examine the impact of local anesthetic on the frequency of vasovagal reactions and the patients perception of pain during femoral arterial sheath removal after percutaneous coronary intervention.

Detailed Description

Patients undergoing percutaneous coronary intervention(PCI) will be randomized to receive subcutaneous local anesthetic (Lidocaine 2% without epinephrine)or no local prior to removal of femoral arterial sheath. They will be assessed for vasovagal reactions and pain intensity during the sheath removal.The incidence of vasovagal reactions and pain intensity scores will be compared between the groups. 200 patients will be enrolled over the course of 2 months.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Syncope, Vasovagal
Pain Intensity

Intervention ^ICMJE

Drug: Subcutaneous Lidocaine 2% (Xylocaine) without epinephrine

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

September 2007

Primary Completion Date

September 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Percutaneous Coronary Intervention
Femoral arterial sheath

Exclusion Criteria:

Less than 18 years old
Emergency procedure
Transferred out of heart investigation unit prior to sheath removal
Radial or brachial sheath
Closure devise
Venous sheath insitu
Intra-aortic balloon pump insitu
Tranvenous pacing
Mechanical ventilation
Cognitive impairment
Unable to read English
Lidocaine allergy

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Canada

Administrative Information

NCT ID ^ICMJE

NCT00465439

Responsible Party

A Cook, Hamilton Health Science

Study ID Numbers ^ICMJE

27071995

Study Sponsor ^ICMJE

Hamilton Health Sciences

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Allison Cook, BScN

Hamilton Health Science

Information Provided By

McMaster University

Verification Date

August 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP