The Impact of Pain Scores on Intrauterine Lidocaine Versus Normal Saline Infusion at the Time of IUD Placement



Status:Completed
Conditions:Chronic Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:18 - 50
Updated:3/1/2014
Start Date:July 2009
End Date:December 2013
Contact:Anita L Nelson, M.D.
Email:anitanelsonwhc@earthlink.net
Phone:310-222-3871

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Double Blind, Randomized, Prospective Trial of Impact of Pain Scores on Intrauterine Lidocaine vs Normal Saline Infusion Before IUD Placement.

The study hypothesis is that infusion of 2% lidocaine at the time of IUD placement will
reduce pain scores related to that procedure. In a double blinded randomized trial of 60
women receiving either normal saline or lidocaine infused through an endometrial aspirator,
pain scores will be obtained for each step of the IUD placement procedure and for the total
experience.

IUDs are the most frequently used method of reversible birth control. In the Women's Health
Care Clinic, more than 10 women a week have IUDs placed. The placement procedure is
straightforward, but can cause the women cramping and pain. Every woman is advised to take
Ibuprofen or acetaminophen prior to her appointment. Gentle techniques and distraction are
used to minimize discomfort. However, some women still have measurable pain during and
immediately after the procedure.

Investigators have shown that infusion of 5cc of a 2% concentration of liquid lidocaine into
the inside of the uterus can reduce the pain that is associated with other procedures, such
as biopsies done of the lining of the uterus. The investigators seek to determine if a
similar infusion made before IUD placement may reduce pain. Because pain is a subjective
complaint and because plastic tubing is being used to sound the uterus instead of the usual
metal probe (a uterine sound), the investigators have included a placebo arm with saline
infusion. All women will receive oral medication in advance of IUD placement, so no woman
will be subject to placebo only. The investigators plan to screen 100 patients to enroll 30
in each arm for a total of 60 patients.

Those women undergoing routine screening for IUD candidacy will be approached. Medical and
social history and routine laboratory testing are to be done. The risks, benefits, and side
effects of IUD placement will be explained. They will sign consent forms for the IUD from
both the manufacturer and the clinic before evaluation for possible inclusion in this study.
Informed consent for the study will be obtained either at that visit or on the day of the
IUD placement. All the routine IUD placement steps will be done and she will rate the pain
score. A standardized pain scale from 1-10, with 10 being the worst pain in the patient's
lifetime, will be used here and at every point in the study. Depth of the uterus will be
determined by introducing a plastic tubing into the woman's uterus. This tubing will either
be filled with 1.3cc of normal saline or 2% lidocaine. The liquid will be infused at
certain points within the cervix and uterus. She will again be asked to rate her pain score
for that procedure. The tubing will be removed and the IUD will be placed. After the IUD is
in the correct position, but before removal of the tenaculum, she will again be asked to
rate her pain score for that procedure. After the IUD placement procedure is complete and
the patient is dressed, she will be asked to assign an overall pain score. Pain scores
between placebo and study drug used will be compared (mean, median and range). Fisher T
tests will be performed to determine statistical significance with the p< 0.05 as a cutoff.
Sub-analysis will be done comparing scores of which women who have never been pregnant to
those who have. If possible, comparisons of pain scores will be made for women who have had
vaginal deliveries compared to those who delivered by C-section. The risks to the patient
for this study intervention are minimal.

Inclusion Criteria:

- Women eligible for IUD insertion

- Willing to give consent

Exclusion Criteria:

- Allergy to lidocaine

- Contraindications to IUD use
We found this trial at
2
sites
Torrance, California 90502
1980
mi
from 43215
Torrance, CA
Click here to add this to my saved trials
Torrance, California 90502
1980
mi
from 43215
Torrance, CA
Click here to add this to my saved trials