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

Hamilton Health Sciences (HHS)

Status: Completed

Conditions: Syncope, Vasovagal; Pain Intensity

Treatments: Drug: Subcutaneous Lidocaine 2% (Xylocaine) without epinephrine

Study type: Interventional

Funder types: Other

Identifiers

NCT00465439

27071995

Details and patient eligibility

About

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.

Full 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.

Enrollment: 78 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)