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Trial record 1 of 1 for:    NCT03654417
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Pain Perception During Vulvar Biopsy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03654417
Recruitment Status : Terminated (interim analysis produced significant results, so we ended enrollment)
First Posted : August 31, 2018
Results First Posted : January 18, 2020
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
Duke University

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.

Condition or disease Intervention/treatment Phase
Any Condition Requiring Vulvar Biopsy Drug: EMLA Drug: Lidocaine Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Comparison of Pain Perception Using Topical EMLA Cream Versus Lidocaine Injection for Vulvar Biopsy: a Randomized Controlled Trial
Actual Study Start Date : September 17, 2018
Actual Primary Completion Date : March 12, 2019
Actual Study Completion Date : March 12, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arm Intervention/treatment
Active Comparator: EMLA Drug: 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.

Active Comparator: Lidocaine Drug: 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.




Primary Outcome Measures :
  1. Highest Pain Score [ Time Frame: 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)



Secondary Outcome Measures :
  1. Pain During Biopsy as Measured by a Pain Scale [ Time Frame: 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)


  2. Baseline Vulvar Pain [ Time Frame: 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)

  3. Anxiety Before the Procedure as Measured by an Anxiety Scale [ Time Frame: 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)


  4. Generalized Anxiety Disorder 7-item (GAD-7) Score for Baseline Anxiety [ Time Frame: 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).

  5. Acceptance of the Procedure as Measured by a Satisfaction Scale [ Time Frame: 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)


  6. Tolerance of Procedure as Measured by a Satisfaction Scale [ Time Frame: 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)


  7. Provider's Opinion of Subject Tolerance as Measured by a Scale [ Time Frame: 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)


  8. Provider's Overall Satisfaction With the Procedure as Measured by a Scale [ Time Frame: 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)




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03654417


Locations
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United States, North Carolina
Duke Univeristy
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Laura Havrilesky, MD Duke University
  Study Documents (Full-Text)

Documents provided by Duke University:
Informed Consent Form  [PDF] November 11, 2018
Study Protocol  [PDF] September 23, 2019
Statistical Analysis Plan  [PDF] April 4, 2019


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03654417    
Other Study ID Numbers: Pro00094298
First Posted: August 31, 2018    Key Record Dates
Results First Posted: January 18, 2020
Last Update Posted: January 18, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Duke University:
vulvar biopsy
Additional relevant MeSH terms:
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Lidocaine
Lidocaine, Prilocaine Drug Combination
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anesthetics, Combined