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Treatment Prior to Injection and Biopsy of the Vulva

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ClinicalTrials.gov Identifier: NCT03444727
Recruitment Status : Recruiting
First Posted : February 23, 2018
Last Update Posted : February 25, 2021
Sponsor:
Information provided by (Responsible Party):
Kirby Woodall, University of Missouri-Columbia

Study Description
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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.

Condition or disease Intervention/treatment Phase
Vulvar Diseases Anesthesia Anesthesia, Local Other: Ice Pre-treatment Other: Room Temperature Water Pre-treatment Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment Prior to Injection and Biopsy of the Vulva
Actual Study Start Date : February 19, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03444727


Locations
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United States, Missouri
Missouri Ob/Gyn Associated Recruiting
Columbia, Missouri, United States, 65202
Contact: Erma Drobnis, PhD    573-817-3124    drobnise@health.missouri.edu   
Contact: Kirby Woodall, MD    573-499-6084    woodallk@health.missouri.edu   
Sponsors and Collaborators
University of Missouri-Columbia
Investigators
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Principal Investigator: Courtney Barnes, MD University of Missouri-Columbia
More Information
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Publications:

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Responsible Party: Kirby Woodall, Resident Physician, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT03444727    
Other Study ID Numbers: 2010101
First Posted: February 23, 2018    Key Record Dates
Last Update Posted: February 25, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kirby Woodall, University of Missouri-Columbia:
vulvar biopsy
ice
anesthesia
pain
vulva
Additional relevant MeSH terms:
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Vulvar Diseases