Intrauterine Lidocaine Infusion for Essure Sterilization Procedures

Phase 4

Completed

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 lidocaine in the uterus by measuring lidocaine levels in the blood.

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 intrauterine lidocaine infusion will decrease the amount of pain subjects experience during and after Essure transcervical tubal sterilization.

We plan to enroll women who have selected Essure as their method of tubal sterilization who will be randomized to one of two groups on the days of their procedures. Subjects in Group 1, the treatment group, will receive a standard paracervical block with lidocaine intrauterine infusion and subjects in Group 2, the control group, will receive a standard paracervical block with saline intrauterine infusion. The subjects will be asked to rate their pain on a 100 mm Visual Analog Scale (VAS) at five points during the procedure and once thirty minutes following the procedure. Subjects will also be asked to rate their overall satisfaction with their care prior to leaving the recovery room.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Lidocaine group	Lidocaine	Participants receive transcervical instillation of 5 ml 4% lidocaine solution 3 minutes prior to transcervical tubal sterilization
Control group	Sterile Saline	Participants receive transcervical instillation of 5 ml saline 3 minutes prior to transcervical tubal sterilization

Primary Outcome Measures

Name	Time	Method
Change in Patient-perceived Pain Between Baseline and Cannulization	Immediately after speculum insertion and immediately after cannulization	Patients rated their pain following speculum insertion (used as baseline) and after insertion of a cannula into both fallopian tubes. Reported pain during cannulization of the right and left fallopian tubes were averaged to obtain the measurement of pain at cannulization. Pain was reported using a Visual Analog Scale (VAS, range 0-100), where a score of 0 indicates no pain and a score of 100 indicates the worst pain imaginable. Baseline pain levels were subtracted from average pain during cannulization: a negative change in VAS score between baseline and cannulization indicates less pain during cannulization and a positive change in VAS score indicates more pain during cannulization.

Secondary Outcome Measures

Name	Time	Method
Patient Perceived Pain 30 Minutes Post-procedure	30 minutes post-procedure	Patients rated their pain 30 minutes after speculum removal using a Visual Analog Scale (VAS, range 0-100), where a score of 0 indicates no pain and a score of 100 indicates the worst pain imaginable.
Patient Satisfaction With the Essure Tubal Sterilization Procedure	30 minutes post-procedure	Patients reported their overall satisfaction with the Essure tubal sterilization procedure using a Visual Analog scale (VAS), range 0-100. A score of 0 indicates lowest possible satisfaction and a score of 100 indicates highest possible satisfaction.

Locations (2): Planned Parenthood of the Columbia Willamette
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Portland, Oregon, United States
Oregon Health & Science University
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Portland, Oregon, United States