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NCT Number: NCT00465439

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

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.

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Key information

Conditions

Syncope, Vasovagal Autonomic Nervous System Diseases Consciousness Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Orthostatic Intolerance Pain Pain Intensity Pathological Conditions, Signs and Symptoms Primary Dysautonomias Signs and Symptoms Syncope Unconsciousness

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hamilton Health Science-Heart Investigation Unit

Hamilton, Ontario, L8N 2S2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Subcutaneous Lidocaine 2% (Xylocaine) without epinephrine

Drug

10 ml subcutaneously

Other names: Xylocaine 2% without epinephrine

Primary outcomes

  1. Incidence of vasovagal reaction during femoral sheath removal

    Time frame: During sheath removal

  2. Pain intensity during femoral sheath removal

    Time frame: During sheath removal

Sponsors and collaborators

Lead sponsor

Hamilton Health Sciences Corporation

Other

Registry information

Official study 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.

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Apr 25, 2007
Registry last updated
Aug 22, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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