Treatment Prior to Injection and Biopsy of the Vulva

March 27, 2022 updated by: Kirby Woodall, University of Missouri-Columbia
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Columbia, Missouri, United States, 65202
        • Missouri Ob/Gyn Associated

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: Ice Pre-treatment
Topical application of ice prior to local anesthetic injection.
Placebo Comparator: 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.
Other: Room Temperature Water Pre-treatment
Topical application of room-temperature water prior to local anesthetic injection.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Missouri-Columbia

Investigators

  • Principal Investigator: Courtney Barnes, MD, University of Missouri-Columbia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 19, 2018

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

February 19, 2018

First Submitted That Met QC Criteria

February 19, 2018

First Posted (Actual)

February 23, 2018

Study Record Updates

Last Update Posted (Actual)

April 6, 2022

Last Update Submitted That Met QC Criteria

March 27, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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