NCT00465439

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2007

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 25, 2007

Completed
6 days until next milestone

Study Start

First participant enrolled

May 1, 2007

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

August 22, 2008

Status Verified

August 1, 2008

Enrollment Period

4 months

First QC Date

April 23, 2007

Last Update Submit

August 21, 2008

Conditions

Syncope, VasovagalPain Intensity

Keywords

femoral artery sheathvasovagal reactionpainperception

Outcome Measures

Primary Outcomes (2)

  • Incidence of vasovagal reaction during femoral sheath removal

    During sheath removal

  • Pain intensity during femoral sheath removal

    During sheath removal

Interventions

Subcutaneous Lidocaine 2% (Xylocaine) without epinephrineDRUG

10 ml subcutaneously

Also known as: Xylocaine 2% without epinephrine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Percutaneous Coronary Intervention
  • Femoral arterial sheath

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hamilton Health Science-Heart Investigation Unit

Hamilton, Ontario, L8N 2S2, Canada

Location

MeSH Terms

Conditions

Syncope, VasovagalPain

Interventions

LidocaineEpinephrine

Condition Hierarchy (Ancestors)

Orthostatic IntolerancePrimary DysautonomiasAutonomic Nervous System DiseasesNervous System DiseasesSyncopeUnconsciousnessConsciousness DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesEthanolaminesAmino AlcoholsAlcoholsBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Allison Cook, BScN

    Hamilton Health Science

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 23, 2007

First Posted

April 25, 2007

Study Start

May 1, 2007

Primary Completion

September 1, 2007

Study Completion

September 1, 2007

Last Updated

August 22, 2008

Record last verified: 2008-08

Locations

CA(1)