Treatment Prior to Injection and Biopsy of the Vulva

Study Overview
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Brief Summary
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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
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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.

Official Title
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Treatment Prior to Injection and Biopsy of the Vulva

Conditions
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Vulvar Diseases, Anesthesia, Anesthesia, Local

Intervention / Treatment
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* Other: Ice Pre-treatment
* Other: Room Temperature Water Pre-treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ice Pre-treatment<br>Participants will hold an exam glove filled with ice to intended biopsy area for 30 seconds prior to preparation and local anesthetic injection. | Other: Ice Pre-treatment<br>* Topical application of ice prior to local anesthetic injection.<br>|
| Placebo Comparator: Room Temperature Water Pre-Treatment<br>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. | Other: Room Temperature Water Pre-treatment<br>* Topical application of room-temperature water prior to local anesthetic injection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-injection Pain Score | 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. | Immediately after local anesthetic injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-procedure satisfaction score | 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. | Immediately after procedure | 
| Post-procedure anxiety score | 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. | Immediately after procedure | 
| Post-procedure pain control score | 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. | Immediately after procedure | 
| Post-biopsy pain score | 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. | Immediately after procedure. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vulvar biopsy, ice, anesthesia, pain, vulva