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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2007-09-30

Brief Summary

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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

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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.

Conditions

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Syncope, Vasovagal Pain Intensity

Keywords

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femoral artery sheath vasovagal reaction pain perception

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Subcutaneous Lidocaine 2% (Xylocaine) without epinephrine

10 ml subcutaneously

Intervention Type DRUG

Other Intervention Names

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Xylocaine 2% without epinephrine

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Hamilton Health Science

Principal Investigators

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Allison Cook, BScN

Role: PRINCIPAL_INVESTIGATOR

Hamilton Health Science

Locations

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Hamilton Health Science-Heart Investigation Unit

Hamilton, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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27071995

Identifier Type: -

Identifier Source: org_study_id