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

Randomized Controlled Trial Examining the Effect of Subcutaneous Xylocaine 2% on the Incidence of Vasovagal Reactions and Pain Intensity During Femoral Artery Sheath Removal.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00465439

Enrollment

Registered

2007-04-25

Start date

2007-05-31

Completion date

2007-09-30

Last updated

2008-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain Intensity, Syncope, Vasovagal

Keywords

femoral artery sheath, vasovagal reaction, pain, perception

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.

Interventions

DRUGSubcutaneous Lidocaine 2% (Xylocaine) without epinephrine

10 ml subcutaneously

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Incidence of vasovagal reaction during femoral sheath removal	During sheath removal
Pain intensity during femoral sheath removal	During sheath removal

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026