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

This study has been completed.
Sponsor:
Information provided by:
McMaster University
ClinicalTrials.gov Identifier:
NCT00465439
First received: April 23, 2007
Last updated: August 21, 2008
Last verified: August 2008
History of Changes
  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
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:

MedlinePlus related topics: Fainting
U.S. FDA Resources

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: A Cook, Hamilton Health Science
ClinicalTrials.gov 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
pain
perception

Additional relevant MeSH terms:
Syncope
Syncope, Vasovagal
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Orthostatic Intolerance
Primary Dysautonomias
Autonomic Nervous System Diseases
Epinephrine
Epinephryl borate
Lidocaine
Anesthetics, Local
 Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Mydriatics
Adrenergic alpha-Agonists

ClinicalTrials.gov processed this record on May 21, 2013