NCT03444727

Treatment Prior to Injection and Biopsy of the Vulva

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: University of Missouri-Columbia · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will compare pre-treatment with ice prior to injection of local anesthetic for vulvar biopsy to no pre-treatment and evaluate pain levels and patient satisfaction with the procedure.

Detailed description

To diagnose skin conditions of the vulva and determine appropriate treatment, a biopsy is often taken as an outpatient procedure. Prior to biopsy, the skin is cleansed and injected with a numbing solution. These injections can be quite painful in this sensitive area. Ice has been used as topical anesthesia in a number of sites, including the cornea, the skin, and particularly in the mouth prior to anesthetic injections. However, there is no evidence for using ice anesthesia prior to injections of the vulvar tissues. The purpose of this study is to evaluate the efficacy of using ice as pre-treatment prior to the injection of local anesthetic for vulvar biopsy.

Conditions

• Vulvar Diseases
• Anesthesia
• Anesthesia, Local

Interventions

Type	Name	Description
OTHER	Ice Pre-treatment	Topical application of ice prior to local anesthetic injection.
OTHER	Room Temperature Water Pre-treatment	Topical application of room-temperature water prior to local anesthetic injection.

Timeline

• Start date: 2018-02-19
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2018-02-23
• Last updated: 2022-04-06

Locations

1 site across 1 country: United States