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

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

ChemIDplus related topics:

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 Hamilton Health Sciences:

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
First Received:	April 23, 2007
Last Updated:	August 21, 2008
ClinicalTrials.gov Identifier:	NCT00465439
Health Authority:	Canada: Ethics Review Committee

Keywords provided by Hamilton Health Sciences:

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 September 05, 2008

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