Randomized Controlled Trial Examining the Effect of Subcutaneous Xylocaine 2% on the Incidence of Vasovagal Reactions and Pain Intensity During Femoral Artery Sheath Removal.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 78
- Locations
- 1
- Primary Endpoint
- Incidence of vasovagal reaction during femoral sheath removal
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Incidence of vasovagal reaction during femoral sheath removal
Time Frame: During sheath removal
Pain intensity during femoral sheath removal
Time Frame: During sheath removal
Secondary Outcomes
No secondary outcomes reported