Intrauterine Lidocaine Infusion for Essure Sterilization Procedures
United States58 participantsStarted 2007-05
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Patient-perceived Pain Between Baseline and Cannulization
Timeframe: Immediately after speculum insertion and immediately after cannulization