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The Effect of Buffered Lidocaine Versus Nonbuffered Lidocaine on Pain Scores During Infiltration for Vulvar Biopsies

NCT02698527 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2018-10-10

No results posted yet for this study

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.

Conditions

  • Genital Diseases, Female

Interventions

DRUG

Non-Buffered Lidocaine

Active comparator

DRUG

Buffered Lidocaine

Experimental, additIon of Sodium Bicarbonate to Lidocaine

Sponsors & Collaborators

  • Women and Infants Hospital of Rhode Island

    lead OTHER

Principal Investigators

  • Jennifer C Villavicencio, MD · Women and Infants Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2018-04-30
Completion
2018-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02698527 on ClinicalTrials.gov