Pain Perception During Vulvar Biopsy

Stopped early · Phase 4

Conditions studied: Any Condition Requiring Vulvar Biopsy

In brief

The purpose of this study is to compare pain control during vulvar biopsy following either (1) application of EMLA (a eutectic mixture of local anesthetics lidocaine 2.5% and prilocaine 2.5%) cream or (2) injection of 1% lidocaine. We hypothesize that lidocaine will provide better biopsy analgesia, but the benefit will be offset by the pain of lidocaine injection compared to EMLA application, thus there will not be a significant difference in highest pain scores between the two groups.

Key facts

Study ID

NCT03654417

Run by

Duke University

People needed

37

Starts

2018-09-17

Expected to finish

2019-03-12

Last updated by the study team

2020-01-18

Who can join

Age: 18 and older, up to 89. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Females above age 18 presenting to Duke Gynecology Oncology clinic for vulvar biopsy
• Able to provide informed consent in English and agree to the risks of the study

You may not qualify if…

• Not able to provide informed consent
• Vulvar biopsy on a hair bearing surface

Where it is running

• Duke Univeristy — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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