Treatment Prior to Injection and Biopsy of the Vulva

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03444727

Enrollment

Registered

2018-02-23

Start date

2018-02-19

Completion date

2021-12-31

Last updated

2022-04-06

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

Conditions

Anesthesia, Anesthesia, Local, Vulvar Diseases

Keywords

vulvar biopsy, ice, anesthesia, pain, vulva

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.

Interventions

OTHERIce Pre-treatment

Topical application of ice prior to local anesthetic injection.

OTHERRoom Temperature Water Pre-treatment

Topical application of room-temperature water prior to local anesthetic injection.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Participants will be randomly assigned to either pre-treatment with ice inside a sterile glove or with room-temperature water inside an exam glove.

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
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-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.

Countries

United States

Outcome results

None listed

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