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

Primary Purpose

Syncope, Vasovagal, Pain Intensity

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Subcutaneous Lidocaine 2% (Xylocaine) without epinephrine
Sponsored by
Hamilton Health Sciences Corporation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Syncope, Vasovagal focused on measuring femoral artery sheath, vasovagal reaction, pain, perception

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Hamilton Health Science-Heart Investigation Unit

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 23, 2007
Last Updated
August 21, 2008
Sponsor
Hamilton Health Sciences Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00465439
Brief Title
Safety/Efficacy Study of Local Anesthetic Prior to Femoral Artery Sheath Removal
Official Title
Randomized Controlled Trial Examining the Effect of Subcutaneous Xylocaine 2% on the Incidence of Vasovagal Reactions and Pain Intensity During Femoral Artery Sheath Removal.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
September 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hamilton Health Sciences Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Syncope, Vasovagal, Pain Intensity
Keywords
femoral artery sheath, vasovagal reaction, pain, perception

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Subcutaneous Lidocaine 2% (Xylocaine) without epinephrine
Other Intervention Name(s)
Xylocaine 2% without epinephrine
Intervention Description
10 ml subcutaneously
Primary Outcome Measure Information:
Title
Incidence of vasovagal reaction during femoral sheath removal
Time Frame
During sheath removal
Title
Pain intensity during femoral sheath removal
Time Frame
During sheath removal

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allison Cook, BScN
Organizational Affiliation
Hamilton Health Science
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hamilton Health Science-Heart Investigation Unit
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 2S2
Country
Canada

12. IPD Sharing Statement

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

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