Safety/Efficacy Study of Local Anesthetic Prior to Femoral Artery Sheath Removal - Full Text View

Sponsored by:	Hamilton Health Sciences
Information provided by:	McMaster University
ClinicalTrials.gov Identifier:	NCT00465439

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

MedlinePlus related topics: Anesthesia Fainting

Drug Information available for: Lidocaine Epinephrine Epinephrine bitartrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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.

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:

10 ml subcutaneously

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

Investigators

Principal Investigator:

Allison Cook, BScN

Hamilton Health Science

More Information

Responsible Party:	Hamilton Health Science ( A Cook )
Study ID Numbers:	27071995
Study First Received:	April 23, 2007
Last Updated:	August 21, 2008
ClinicalTrials.gov Identifier:	NCT00465439
Health Authority:	Canada: Ethics Review Committee

Keywords provided by McMaster University:

femoral artery sheath
vasovagal reaction
pain
perception

Study placed in the following topic categories:

Signs and Symptoms
Unconsciousness
Consciousness Disorders
Lidocaine
Neurologic Manifestations

Pain
Epinephrine
Neurobehavioral Manifestations
Syncope
Syncope, Vasovagal

Additional relevant MeSH terms:

Respiratory System Agents
Neurotransmitter Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anesthetics
Adrenergic Agonists
Sensory System Agents
Therapeutic Uses
Vasoconstrictor Agents
Anti-Arrhythmia Agents
Adrenergic alpha-Agonists
Adrenergic beta-Agonists

Sympathomimetics
Nervous System Diseases
Anti-Asthmatic Agents
Central Nervous System Depressants
Cardiovascular Agents
Pharmacologic Actions
Anesthetics, Local
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents
Bronchodilator Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009