Safety/Efficacy Study of Local Anesthetic Prior to Femoral Artery Sheath Removal
- Conditions
- Syncope, VasovagalPain Intensity
- Registration Number
- NCT00465439
- Lead Sponsor
- Hamilton Health Sciences Corporation
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 78
- Percutaneous Coronary Intervention
- Femoral arterial sheath
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Incidence of vasovagal reaction during femoral sheath removal During sheath removal Pain intensity during femoral sheath removal During sheath removal
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Hamilton Health Science-Heart Investigation Unit
🇨🇦Hamilton, Ontario, Canada