Intrauterine Lidocaine Infusion for Essure Sterilization Procedures

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 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.

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.