Treatment Prior to Injection and Biopsy of the Vulva

University of Missouri (MU)

Status: Terminated

Conditions: Anesthesia, Local; Vulvar Diseases; Anesthesia

Treatments: Other: Room Temperature Water Pre-treatment; Other: Ice Pre-treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT03444727

2010101

Details and patient eligibility

About

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.

Full 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.

Enrollment: 13 patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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13 participants in 2 patient groups, including a placebo group

Ice Pre-treatment

Experimental group

Description:

Participants will hold an exam glove filled with ice to intended biopsy area for 30 seconds prior to preparation and local anesthetic injection.

Treatment:

Other: Ice Pre-treatment

Room Temperature Water Pre-Treatment

Placebo Comparator group

Description:

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.

Treatment:

Other: Room Temperature Water Pre-treatment