Pain Perception During Vulvar Biopsy

Phase 4 Terminated 37 enrolled Duke University

RandomizedParallel-groupOpen-labelSupportive care

Summary

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.

Timeline

Start: 2018-09-17
Primary completion: 2019-03-12
Completion: 2019-03-12

Outcome

Outcome not reported

Stopped (Enrollment): “interim analysis produced significant results, so we ended enrollment”

Publications

Williams LK, Weber JM, Pieper C, Lorenzo A, Moss H, Havrilesky LJ. Lidocaine-Prilocaine Cream Compared With Injected Lidocaine for Vulvar Biopsy: A Randomized Controlled Trial. Obstet Gynecol. 2020 Feb;135(2):311-318. doi: 10.1097/AOG.0000000000003660.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	EMLA	Unknown	2.5 %	Topical
Comparator	Lidocaine	Other / unclassified	1 %	Other