Status:
COMPLETED
Intrauterine Lidocaine Infusion for Essure Sterilization Procedures
Lead Sponsor:
Oregon Health and Science University
Conditions:
Pain
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief 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 lidocain...
Detailed Description
We intend to conduct a randomized, blinded, and placebo- controlled clinical trial at Oregon Health and Science University and Planned Parenthood of the Columbia Willamette to determine if intrauterin...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT00613834
Start Date
May 1 2007
End Date
June 1 2008
Last Update
December 19 2019
Active Locations (2)
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1
Planned Parenthood of the Columbia Willamette
Portland, Oregon, United States, 97206
2
Oregon Health & Science University
Portland, Oregon, United States, 97239