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

Syncope, Vasovagal Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00465439
• Other study ID #: 27071995
• Status: Completed
• Phase: N/A
• First received: April 23, 2007
• Last updated: August 21, 2008
• Start date: May 2007
• Est. completion date: September 2007

Study information

• Verified date: August 2008
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain Intensity
• Syncope, Vasovagal

Intervention

Drug:
• Subcutaneous Lidocaine 2% (Xylocaine) without epinephrine
10 ml subcutaneously

Locations

Country	Name	City	State
Canada	Hamilton Health Science-Heart Investigation Unit	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Hamilton Health Sciences Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of vasovagal reaction during femoral sheath removal		During sheath removal	No
Primary	Pain intensity during femoral sheath removal		During sheath removal	No