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Intrauterine Lidocaine Infusion for Essure Sterilization Procedures

NCT00613834 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2019-12-19

Study results available
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Summary

The purpose of this study is to assess the level of pain women experience with an Essure procedure and the effect that lidocaine might have on that pain. We will also assess the absorption of lidocaine in the uterus by measuring lidocaine levels in the blood.

Conditions

Interventions

DRUG

Lidocaine

5 ml intrauterine infusion of 4% lidocaine using a sterile 3 mm Novak curette will be infused slowly over 4 1/2 minutes

DRUG

Sterile Saline

5 ml intrauterine infusion of sterile saline using a sterile 3 mm Novak curette will be infused slowly over 4 1/2 minutes

Sponsors & Collaborators

  • Oregon Health and Science University

    lead OTHER

Principal Investigators

  • Michelle M. Isley, M.D. · Oregon Health and Science University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2008-06-30
Completion
2008-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT00613834 on ClinicalTrials.gov