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

This study has been completed.
Information provided by:
McMaster University Identifier:
First received: April 23, 2007
Last updated: August 21, 2008
Last verified: August 2008
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]
  • Pain intensity during femoral sheath removal [ Time Frame: During sheath removal ] [ Designated as safety issue: No ]

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.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00465439

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

Responsible Party: A Cook, Hamilton Health Science Identifier: NCT00465439     History of Changes
Other Study ID Numbers: 27071995 
Study First Received: April 23, 2007
Last Updated: August 21, 2008
Health Authority: Canada: Ethics Review Committee

Keywords provided by McMaster University:
femoral artery sheath
vasovagal reaction

Additional relevant MeSH terms:
Syncope, Vasovagal
Autonomic Nervous System Diseases
Consciousness Disorders
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Orthostatic Intolerance
Primary Dysautonomias
Signs and Symptoms
Epinephryl borate
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-Agonists
Adrenergic beta-Agonists
Anesthetics, Local
Anti-Arrhythmia Agents
Anti-Asthmatic Agents
Autonomic Agents
Bronchodilator Agents
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action processed this record on May 04, 2016