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

Sponsor:	Hamilton Health Sciences Corporation
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

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

Drug Information available for: Epinephrine bitartrate Epinephrine Lidocaine

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:

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
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
Sympathomimetics

ClinicalTrials.gov processed this record on February 12, 2012