NCT03654417

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2018

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 29, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 31, 2018

Completed
17 days until next milestone

Study Start

First participant enrolled

September 17, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 12, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 12, 2019

Completed
10 months until next milestone

Results Posted

Study results publicly available

January 18, 2020

Completed
Last Updated

January 18, 2020

Status Verified

January 1, 2020

Enrollment Period

6 months

First QC Date

August 29, 2018

Results QC Date

December 20, 2019

Last Update Submit

January 9, 2020

Conditions

Any Condition Requiring Vulvar Biopsy

Keywords

vulvar biopsy

Outcome Measures

Primary Outcomes (1)

  • Highest Pain Score

    The highest pain score recorded (at time of numbing or at time of biopsy) controlled for baseline pain title: Please slide the tab along the line below to indicate pain in the area of your vulva (external genitalia) during numbing OR biopsy min: 0 (no pain) max: 100 (worst pain imaginable)

    no more than 5 minutes after numbing or 5 minutes after biopsy

Secondary Outcomes (8)

  • Pain During Biopsy as Measured by a Pain Scale

    No more than 5 minutes after receiving the biopsy

  • Baseline Vulvar Pain

    no more than 30 minutes prior to procedure

  • Anxiety Before the Procedure as Measured by an Anxiety Scale

    No more than 30 minutes before the procedure

  • Generalized Anxiety Disorder 7-item (GAD-7) Score for Baseline Anxiety

    no more than 30 minutes before the procedure

  • Acceptance of the Procedure as Measured by a Satisfaction Scale

    up to 30 minutes after the procedure

  • +3 more secondary outcomes

Study Arms (2)

EMLA

ACTIVE COMPARATOR
Drug: Lidocaine

Lidocaine

ACTIVE COMPARATOR
Drug: EMLA

Interventions

EMLADRUG

Patients undergoing a vulvar biopsy will be randomized to receive EMLA cream or a lidocaine injection as their numbing agent prior to the procedure.

Lidocaine
LidocaineDRUG

Patients undergoing a vulvar biopsy will be randomized to receive EMLA cream or a lidocaine injection as their numbing agent prior to the procedure.

EMLA

Eligibility Criteria

Age18 Years - 89 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke Univeristy

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

  • 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.

    PMID: 31923074DERIVED

MeSH Terms

Interventions

Lidocaine

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Limitations and Caveats

unblinded patients and providers, prior experience with vulvar biopsy may be biasing, pre-procedure anxiety may be biased because posed after randomization, no gold standard for pain assessment

Results Point of Contact

Title
Dr. Laura Havrilesky
Organization
Duke University
laura.havrilesky@duke.edu
(919) 684-0188

Study Officials

  • Laura Havrilesky, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2018

First Posted

August 31, 2018

Study Start

September 17, 2018

Primary Completion

March 12, 2019

Study Completion

March 12, 2019

Last Updated

January 18, 2020

Results First Posted

January 18, 2020

Record last verified: 2020-01

Locations

US(1)