This phase IV trial studies how well topical EMLA cream works compared to a lidocaine injection in reducing pain in patients undergoing a vulvar biopsy. Topical EMLA cream and lidocaine are both numbing medicines that help reduce pain before and during a vulvar biopsy. It is not yet known whether topical EMLA cream or a lidocaine injection helps reduce pain better than the other in patients undergoing a vulvar biopsy.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03654417.
PRIMARY OBJECTIVES
I. To compare highest subjective pain score with application of eutectic mixture of local anesthetics (EMLA) cream versus injection of lidocaine for analgesia for vulvar biopsy.
SECONDARY OBJECTIVES
I. To compare pain scores at vulvar biopsy.
EXPLORATORY OBJECTIVES
I. To compare subjects’ and providers’ perceptions of acceptability and tolerability of the procedure between EMLA application and lidocaine injection.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients receive EMLA cream topically at the intended site for a minimum of 10 minutes before undergoing a vulvar biopsy.
GROUP II: Patients receive a lidocaine injection at the planned site at least 1 minute before undergoing a vulvar biopsy.
Trial PhasePhase IV
Trial Typesupportive care
Lead OrganizationDuke University Medical Center
Principal InvestigatorLaura J. Havrilesky
