The Effect of Buffered Lidocaine Versus Nonbuffered Lidocaine on Pain Scores During Infiltration for Vulvar Biopsies
1 other identifier
interventional
128
1 country
2
Brief Summary
Objective: To compare pain scores on a visual analogue scale during infiltration of local anesthetic for vulvar biopsies between women who are treated with buffered versus non- buffered lidocaine Hypothesis: Patients treated with buffered lidocaine at the site of vulvar biopsy will have lower pain scores on a visual analogue scale during the biopsy. Study Design: Double blinded randomized controlled trial Population: Women undergoing vulvar biopsy at the Women's Primary Care Center and The Program In Women's Oncology Clinic of a non-infectious vulvar lesion.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2015
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 18, 2015
CompletedStudy Start
First participant enrolled
June 1, 2015
CompletedFirst Posted
Study publicly available on registry
March 3, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2018
CompletedOctober 10, 2018
October 1, 2018
2.8 years
May 18, 2015
October 7, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Pain scores on Visual Analogue Pain Scale (100mm)
Before procedure, approximately 5 minutes
Pain scores on Visual Analogue Pain Scale (100mm)
During infiltration of lidocaine, approximately 10 minutes
Pain scores on Visual Analogue Pain Scale (100mm)
After completion of procedure, approximately 5 minutes
Study Arms (2)
Non-Buffered Lidocaine
ACTIVE COMPARATORVulvar biopsy conducted using non-buffered lidocaine as anesthesia
Buffered Lidocaine
EXPERIMENTALVulvar biopsy conducted using buffered lidocaine as anesthesia
Interventions
Eligibility Criteria
You may qualify if:
- Patient at the Women's Primary Care Center
- Ages 18 and older
- Require a vulvar biopsy for a noninfectious vulvar lesion.
- Able to read English or Spanish
- Able to give informed consent for involvement in the study
You may not qualify if:
- Allergy to lidocaine
- Unable to give informed consent
- Unable to read English or Spanish
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Women and Infants Hospital, Program in Women's Oncology
Providence, Rhode Island, 02905, United States
Women's Primary Care Center/Women and Infants' Hospital
Providence, Rhode Island, 02905, United States
Related Publications (1)
Villavicencio JC, Kulkarni A, Luis C, Mendez H, Raker C, Cronin B, Robison K. Sensation of Pain Using Buffered Lidocaine for Infiltration Before Vulvar Biopsy: A Randomized Controlled Trial. Obstet Gynecol. 2020 Mar;135(3):609-614. doi: 10.1097/AOG.0000000000003710.
PMID: 32028501DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jennifer C Villavicencio, MD
Women and Infants Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Invesitgator
Study Record Dates
First Submitted
May 18, 2015
First Posted
March 3, 2016
Study Start
June 1, 2015
Primary Completion
April 1, 2018
Study Completion
April 1, 2018
Last Updated
October 10, 2018
Record last verified: 2018-10