Safety/Efficacy Study of Local Anesthetic Prior to Femora... | NCT00465439

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

NCT00465439

Sponsor

Hamilton Health Sciences Corporation

Status

Completed

Last Update Posted

Aug 22, 2008Estimated

Enrollment

78Actual

Phase

Not Applicable

Conditions

Syncope, Vasovagal
Pain Intensity

Interventions

Subcutaneous Lidocaine 2% (Xylocaine) without epinephrine

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2007

Primary Completion Date

Sep 2007Actual

Completion Date

Sep 2007Actual

First Submitted Date

Apr 23, 2007

First Submission Date that Met QC Criteria

Apr 24, 2007

First Posted Date

Apr 25, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 21, 2008

Last Update Posted Date

Aug 22, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

78Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Subcutaneous Lidocaine 2% (Xylocaine) without epinephrine	Drug	10 ml subcutaneously		Xylocaine 2% without epinephrine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of vasovagal reaction during femoral sheath removal		During sheath removal
Pain intensity during femoral sheath removal		During sheath removal

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Allison Cook, BScN	Hamilton Health Science	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hamilton Health Science-Heart Investigation Unit		Hamilton	Ontario	L8N 2S2	Canada

Condition Browse Module

MeSH Terms

ID	Term
D019462	Syncope, Vasovagal
D010146	Pain

Ancestor Terms

ID	Term
D054971	Orthostatic Intolerance
D054969	Primary Dysautonomias
D001342	Autonomic Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008012	Lidocaine
D004837	Epinephrine

Ancestor Terms

ID	Term
D000083	Acetanilides
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814

Browse Leaves

Not provided

Browse Branches

Not provided