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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00465439
First Posted: April 25, 2007
Last Update Posted: August 22, 2008
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.
Information provided by:
McMaster University
  Purpose
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 Intervention
Syncope, Vasovagal Pain Intensity Drug: Subcutaneous Lidocaine 2% (Xylocaine) without epinephrine

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by McMaster University:

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

Enrollment: 78
Study Start Date: May 2007
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Subcutaneous Lidocaine 2% (Xylocaine) without epinephrine
    10 ml subcutaneously
    Other Name: Xylocaine 2% without epinephrine
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00465439


Locations
Canada, Ontario
Hamilton Health Science-Heart Investigation Unit
Hamilton, Ontario, Canada, L8N 2S2
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Investigators
Principal Investigator: Allison Cook, BScN Hamilton Health Science
  More Information

Responsible Party: A Cook, Hamilton Health Science
ClinicalTrials.gov Identifier: NCT00465439     History of Changes
Other Study ID Numbers: 27071995
First Submitted: April 23, 2007
First Posted: April 25, 2007
Last Update Posted: August 22, 2008
Last Verified: August 2008

Keywords provided by McMaster University:
femoral artery sheath
vasovagal reaction
pain
perception

Additional relevant MeSH terms:
Syncope
Pain
Syncope, Vasovagal
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Orthostatic Intolerance
Primary Dysautonomias
Autonomic Nervous System Diseases
Lidocaine
Epinephrine
Racepinephrine
Epinephryl borate
Anesthetics, Local
Anesthetics
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