Treatment Prior to Injection and Biopsy of the Vulva

Not Applicable

Terminated

• Conditions: Vulvar Diseases; Anesthesia; Anesthesia, Local
• Interventions: Other: Ice Pre-treatment; Other: Room Temperature Water Pre-treatment

• Registration Number: NCT03444727
• Lead Sponsor: University of Missouri-Columbia

Brief 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.

Study Timeline

• Study Start: 2018-02-19
• Study First Submitted: 2018-02-19
• Study First Submitted QC: 2018-02-19
• Study First Posted: 2018-02-23
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-27
• Last Update Posted: 2022-04-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 13

Inclusion Criteria

• Female
• 18 years of age or older
• Undergoing vulva biopsy during clinic visit
• Willing and able to comply with study protocol
• Able to understand and provide informed consent

Exclusion Criteria

• Inability to provide informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ice Pre-treatment	Ice Pre-treatment	Participants will hold an exam glove filled with ice to intended biopsy area for 30 seconds prior to preparation and local anesthetic injection.
Room Temperature Water Pre-Treatment	Room Temperature Water Pre-treatment	Participants will hold an exam glove filled with room temperature water to intended biopsy area for 30 seconds prior to preparation and local anesthetic injection.

Primary Outcome Measures

Name	Time	Method
Post-injection Pain Score	Immediately after local anesthetic injection	Patient's self-reported visual analogue pain scale (100 millimeter) after injection of local anesthetic. Range from 0 to 100 mm, with 0 being least amount of pain and 100 being the most amount of pain.

Secondary Outcome Measures

Name	Time	Method
Post-biopsy pain score	Immediately after procedure.	Patient's self-reports visual analogue pain scale (100 millimeter) score immediately after biopsy. Range from 0mm to 100mm, with 0 being the the least pain and 100 being the most pain.
Post-procedure pain control score	Immediately after procedure	Patient's self-reported visual analogue scale (100 millimeter) for satisfaction with pain control during procedure. Range from 0mm to 100mm with 0 being the least satisfied with pain control and 100mm being the most satisfied with pain control.
Post-procedure satisfaction score	Immediately after procedure	Patient's self-reported visual analogue scale (100 millimeter) for satisfaction with the procedure. Range form 0mm to 100mm with 0 being the least satisfied and 100 being the most satisfied.
Post-procedure anxiety score	Immediately after procedure	Patient's self-reported visual analogue scale (100 millimeter) score for anxiety level about having another vulvar biopsy in the future. Range from 0mm to 100mm, with 0 being the least anxious and 100 being the most anxious about a future procedure.

Trial Locations

Locations (1)

Missouri Ob/Gyn Associated; 🇺🇸 Columbia, Missouri, United States