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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00465439
Recruitment Status : Completed
First Posted : April 25, 2007
Last Update Posted : August 22, 2008
Information provided by:
McMaster University

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.

Condition or disease Intervention/treatment Phase
Syncope, Vasovagal Pain Intensity Drug: Subcutaneous Lidocaine 2% (Xylocaine) without epinephrine Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : May 2007
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2007

Intervention Details:
  • Drug: Subcutaneous Lidocaine 2% (Xylocaine) without epinephrine
    10 ml subcutaneously
    Other Name: Xylocaine 2% without epinephrine

Primary Outcome Measures :
  1. Incidence of vasovagal reaction during femoral sheath removal [ Time Frame: During sheath removal ]
  2. Pain intensity during femoral sheath removal [ Time Frame: During sheath removal ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00465439

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Canada, Ontario
Hamilton Health Science-Heart Investigation Unit
Hamilton, Ontario, Canada, L8N 2S2
Sponsors and Collaborators
Hamilton Health Sciences Corporation
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Principal Investigator: Allison Cook, BScN Hamilton Health Science
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Responsible Party: A Cook, Hamilton Health Science Identifier: NCT00465439    
Other Study ID Numbers: 27071995
First Posted: April 25, 2007    Key Record Dates
Last Update Posted: August 22, 2008
Last Verified: August 2008
Keywords provided by McMaster University:
femoral artery sheath
vasovagal reaction
Additional relevant MeSH terms:
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Syncope, Vasovagal
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Orthostatic Intolerance
Primary Dysautonomias
Autonomic Nervous System Diseases
Epinephryl borate
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents