Intrauterine Lidocaine Infusion for Essure Sterilization Procedures

Completed · Phase 4

Conditions studied: Pain

In brief

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.

Key facts

Study ID

NCT00613834

Run by

Oregon Health and Science University

People needed

58

Starts

2007-05-01

Expected to finish

2008-06-01

Last updated by the study team

2019-12-19

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Female
• Age 18 or older
• Good general health, based on the opinion of the investigator
• Voluntarily requesting permanent sterilization
• Negative pregnancy test
• Agree to premedication with ibuprofen and ativan
• English speaking, or other language if an interpreter is available to be present at all points of the study procedure.
• Willing and able to sign an informed consent
• Willing to comply with the terms of the study

You may not qualify if…

• Significant physical or mental health condition, based on the opinion of the investigator.
• Positive pregnancy test
• Request for IV/IM sedation prior to the start of the procedure
• Refusal of ibuprofen, ativan, or paracervical block
• Allergy to any study medication including lidocaine, ibuprofen, ativan, sodium bicarbonate
• History of toxic reaction to local anesthetics
• Known hepatic disease or liver dysfunction. (Lidocaine is metabolized by the liver.)
• Weight less than 100 pounds. [Any patient weighing less than 100 pounds would receive more than the recommended dose for their weight (4.5 mg/kg or 2 mg/lb)].
• Current participation in another research study which would interfere with the conduct of this study.

Where it is running

• Planned Parenthood of the Columbia Willamette — Portland, Oregon, United States
• Oregon Health & Science University — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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