Topical Lidocaine on the Cervix and Intra-Cervical Prior to Insertion of Intrauterine Devices

There have been multiple studies performed to determine a medication that will decrease the
pain associated with intrauterine device insertion. These studies have tested the use of
misoprostol as well as NSAIDS to determine if these decrease the pain associated with
insertion. There has also been one small, poorly performed, study that tested the use of
intracervical topical lidocaine prior to IUD insertion. Misoprostol and NSAIDS were found to
be non-efficacious in decreasing pain. Topical lidocaine was shown to be effective, however,
secondary to this being a poorly performed study, additional studies are needed. This study
is to determine if topical lidocaine does indeed decrease the pain associated with insertion
of the Mirena® (levonorgestrel intrauterine device).

This is a double blinded experimental study to determine whether or not topical lidocaine
gel applied to the cervix and intra-cervically decreases pain associated with insertion of
the Mirena® (levonorgestrel intrauterine device). Subjects will be randomized into two
groups. One group will receive 2% lidocaine gel on the cervix and intra-cervically. The
other group will receive a placebo, which will consist of KY being placed on the cervix and
intra-cervically. After the Mirena® (levonorgestrel intrauterine device) is inserted, each
subject's pain will be assessed by using a visual analog pain scale, and their response will
be recorded on the information form. This pain scale will be assessed at the time of
insertion, five minutes after insertion, and ten minutes after insertion. The only other
study that researched the use of topical lidocaine prior to insertion of an IUD only
recorded a pain scale at the time of insertion. Additional scores will be recorded at five
and ten minutes to determine if pain is reduced in those time periods. These time periods
have been chosen in order that all of this information can be recorded during a normal
office visit. A visual analog pain scale is the scale included which measures pain on a
scale of zero to ten with zero being no pain at all and ten being the worst pain of your
life. This pain scale will be a scale ranging from zero to ten with faces depicting the
amount of pain involved for each score. Since there will be different physicians placing the
intrauterine devices, there will be a protocol on how to perform the insertion in an attempt
to make all insertions as uniform as possible. A copy of this protocol has been included.

Inclusion Criteria:

1. Any subject receiving a Mirena® (levonorgestrel intrauterine device) for standard
indications.

2. Subjects who received nonsteroidal anti-inflammatory drugs (NSAIDS) will not be
excluded.

Exclusion Criteria:

1. Subjects do not desire to be involved in the study

2. Subjects who have taken narcotics.

3. If the Mirena® (levonorgestrel intrauterine device) is not able to be successfully
placed.

4. If cervical dilation is required, these subjects will be placed in a separate subset
and will be reported on separately.

5. Subject has allergy to lidocaine.