Trial Outcomes & Findings for Pain Perception During Vulvar Biopsy (NCT NCT03654417)

NCT ID: NCT03654417

Last Updated: 2020-01-18

Results Overview

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)

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 37 participants
• Primary outcome timeframe: no more than 5 minutes after numbing or 5 minutes after biopsy
• Results posted on: 2020-01-18

Participant Flow

Participant milestones

Measure	EMLA Lidocaine: 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 EMLA: Patients undergoing a vulvar biopsy will be randomized to receive EMLA cream or a lidocaine injection as their numbing agent prior to the procedure.
Overall Study STARTED	19	18
Overall Study COMPLETED	19	18
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pain Perception During Vulvar Biopsy

Baseline characteristics by cohort

Measure	EMLA n=19 Participants Lidocaine: 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 n=18 Participants EMLA: Patients undergoing a vulvar biopsy will be randomized to receive EMLA cream or a lidocaine injection as their numbing agent prior to the procedure.	Total n=37 Participants Total of all reporting groups
Age, Continuous	60 years n=5 Participants	58.5 years n=7 Participants	60 years n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	18 Participants n=7 Participants	37 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=5 Participants	18 Participants n=7 Participants	36 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants	9 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants	9 Participants n=7 Participants	21 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

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

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)

Outcome measures

Measure	EMLA n=19 Participants Lidocaine: 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 n=18 Participants EMLA: Patients undergoing a vulvar biopsy will be randomized to receive EMLA cream or a lidocaine injection as their numbing agent prior to the procedure.
Highest Pain Score	20 units on a scale (mm) Interval 5.0 to 50.0	56.5 units on a scale (mm) Interval 26.0 to 80.0

SECONDARY outcome

Timeframe: No more than 5 minutes after receiving the biopsy

self-reported level of pain following the biopsy

title: Please slide the tab along the line below to indicate pain in the area of your vulva (external genitalia) during biopsy min: 0 (no pain) max: 100 (worst pain imaginable)

Outcome measures

Measure	EMLA n=19 Participants Lidocaine: 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 n=18 Participants EMLA: Patients undergoing a vulvar biopsy will be randomized to receive EMLA cream or a lidocaine injection as their numbing agent prior to the procedure.
Pain During Biopsy as Measured by a Pain Scale	6 units on a scale (mm) Interval 1.0 to 50.0	3 units on a scale (mm) Interval 0.0 to 15.0

SECONDARY outcome

Timeframe: no more than 30 minutes prior to procedure

self-reported level of vulvar pain immediately prior to the start of the procedure title: Please slide the tab along the line below to indicate pain in the area of your vulva (external genitalia) during biopsy min: 0 (no pain) max: 100 (worst pain imaginable)

Outcome measures

Measure	EMLA n=19 Participants Lidocaine: 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 n=18 Participants EMLA: Patients undergoing a vulvar biopsy will be randomized to receive EMLA cream or a lidocaine injection as their numbing agent prior to the procedure.
Baseline Vulvar Pain	0.0 units on a scale (mm) Interval 0.0 to 5.0	0.0 units on a scale (mm) Interval 0.0 to 3.0

SECONDARY outcome

Timeframe: No more than 30 minutes before the procedure

self-reported level of anxiety immediately prior to the start of the procedure

title: Slide the tab along the line below to indicate how nervous you feel about the procedure you are about to have min: 0 (not nervous) max: 100 (very nervous)

Outcome measures

Measure	EMLA n=19 Participants Lidocaine: 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 n=18 Participants EMLA: Patients undergoing a vulvar biopsy will be randomized to receive EMLA cream or a lidocaine injection as their numbing agent prior to the procedure.
Anxiety Before the Procedure as Measured by an Anxiety Scale	19 units on a scale (mm) Interval 0.0 to 31.0	31.5 units on a scale (mm) Interval 12.0 to 61.0

SECONDARY outcome

Timeframe: no more than 30 minutes before the procedure

Self-reported anxiety score meant to assess a patient's baseline level of anxiety. The score ranges from 0 (minimal anxiety) to 21 (severe anxiety).

Outcome measures

Measure	EMLA n=19 Participants Lidocaine: 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 n=18 Participants EMLA: Patients undergoing a vulvar biopsy will be randomized to receive EMLA cream or a lidocaine injection as their numbing agent prior to the procedure.
Generalized Anxiety Disorder 7-item (GAD-7) Score for Baseline Anxiety Minimal Anxiety (0-4)	13 Participants	11 Participants
Generalized Anxiety Disorder 7-item (GAD-7) Score for Baseline Anxiety Mild Anxiety (5-9)	5 Participants	5 Participants
Generalized Anxiety Disorder 7-item (GAD-7) Score for Baseline Anxiety Moderate Anxiety (10-14)	0 Participants	1 Participants
Generalized Anxiety Disorder 7-item (GAD-7) Score for Baseline Anxiety Severe Anxiety (15-21)	1 Participants	1 Participants

SECONDARY outcome

Timeframe: up to 30 minutes after the procedure

self-reported acceptance of the procedure meant to assess a patient's acceptability through a scale

title: Please slide the tab along the line below to indicate, overall, how acceptable the procedure performed today was min: 0 (completely acceptable) max: 100 (not at all acceptable)

Outcome measures

Measure	EMLA n=19 Participants Lidocaine: 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 n=18 Participants EMLA: Patients undergoing a vulvar biopsy will be randomized to receive EMLA cream or a lidocaine injection as their numbing agent prior to the procedure.
Acceptance of the Procedure as Measured by a Satisfaction Scale	0 units on a scale (mm) Interval 0.0 to 18.0	10.5 units on a scale (mm) Interval 1.0 to 33.0

SECONDARY outcome

Timeframe: Up to 30 minutes after the procedure

self-reported tolerance of the procedure meant to assess a patient's tolerance through a scale

Title: Please slide the tab along the line below to indicate, overall, how you would rate the experience of your biopsy procedure today Min: 0 (I could easily handle having this procedure again) Max: 100 (I could never have this procedure done again)

Outcome measures

Measure	EMLA n=19 Participants Lidocaine: 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 n=18 Participants EMLA: Patients undergoing a vulvar biopsy will be randomized to receive EMLA cream or a lidocaine injection as their numbing agent prior to the procedure.
Tolerance of Procedure as Measured by a Satisfaction Scale	2 units on a scale (mm) Interval 0.0 to 17.0	17 units on a scale (mm) Interval 5.0 to 38.0

SECONDARY outcome

Timeframe: Up to 30 minutes after the procedure

provider-reported measure of how well they believe the patient tolerated the procedure

title: Overall, how well did the subject tolerate the procedure today? min: 0 (well tolerated) max: 100 (poorly tolerated)

Outcome measures

Measure	EMLA n=19 Participants Lidocaine: 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 n=18 Participants EMLA: Patients undergoing a vulvar biopsy will be randomized to receive EMLA cream or a lidocaine injection as their numbing agent prior to the procedure.
Provider's Opinion of Subject Tolerance as Measured by a Scale	3 units on a scale (mm) Interval 0.0 to 19.0	15 units on a scale (mm) Interval 9.0 to 27.0

SECONDARY outcome

Timeframe: Up to 30 minutes after the procedure

provider-reported measure of how well they believe the procedure went

title: Overall, how satisfied are you with the procedure performed today? min: 0 (completely satisfied) max: 100 (not at all satisfied)

Outcome measures

Measure	EMLA n=19 Participants Lidocaine: 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 n=18 Participants EMLA: Patients undergoing a vulvar biopsy will be randomized to receive EMLA cream or a lidocaine injection as their numbing agent prior to the procedure.
Provider's Overall Satisfaction With the Procedure as Measured by a Scale	3 units on a scale (mm) Interval 0.0 to 18.0	9.5 units on a scale (mm) Interval 3.0 to 18.0

POST_HOC outcome

Timeframe: retrospective

To address the concern that EMLA might induce pathologic changes that could result in altered diagnosis, pathologist independent from initial diagnostic read will re-evaluate tissue slides and look for the previously described EMLA induced pathologic changes (pallor, necrosis, spongiosis, basophilic granules, acantholysis, clefting, papillary dermal edema). Pathologist will be blinded to whether or not patient received EMLA cream for biopsy. They will provide a score for all specimens that will be used to analyse any pathologic differences between patients exposed to EMLA and those not exposed to EMLA.

Outcome measures

Outcome data not reported

Adverse Events

EMLA

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Lidocaine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Laura Havrilesky

Duke University

Phone: (919) 684-0188

Email: laura.havrilesky@duke.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place