Intracervical Lidocaine Gel for IUD Insertional Pain
| Status: | Completed |
|---|---|
| Conditions: | Chronic Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 4/21/2016 |
| Start Date: | October 2010 |
| End Date: | June 2013 |
Intracervical Two Percent Lidocaine Gel as an Analgesic During Intrauterine Device Insertion: A Randomized Controlled Trial
The intrauterine device (IUD) is a form of birth control that is extremely effective and
safe, even in women who have not yet had children. Women can experience high levels of pain
when the IUD is placed inside the uterus, and fear of this pain could be a reason that women
decide not to use this method.
This study will randomly (like flipping a coin) assign women who have chosen the IUD as
their contraceptive into two groups. One group will have lidocaine anesthetic gel placed
into their cervix prior to having the IUD inserted; the other will have an inert gel placed
into their cervix instead. The level of pain at three different time points on a 10cm scale
and the patient's satisfaction with the procedure will be compared between the two groups to
see if using lidocaine gel helps decrease IUD insertional pain
safe, even in women who have not yet had children. Women can experience high levels of pain
when the IUD is placed inside the uterus, and fear of this pain could be a reason that women
decide not to use this method.
This study will randomly (like flipping a coin) assign women who have chosen the IUD as
their contraceptive into two groups. One group will have lidocaine anesthetic gel placed
into their cervix prior to having the IUD inserted; the other will have an inert gel placed
into their cervix instead. The level of pain at three different time points on a 10cm scale
and the patient's satisfaction with the procedure will be compared between the two groups to
see if using lidocaine gel helps decrease IUD insertional pain
The intrauterine device (IUD) is a highly effective, long-acting, reversible method of
contraception used by approximately 8% of women in the developed world. In the United
States, historically candidates for IUDs were monogamous, parous women. Recent research has
shown that both copper and levonorgestrel IUD use is safe and effective in nulliparous
women. Nulliparous and parous women can experience significant amounts of pain during IUD
insertion. Concerns about insertional pain could be a barrier to IUD initiation women and
their healthcare providers.
This study will recruit women at either the Family Planning Clinic or the offices of
Columbia University Family Planning Practice who desire the copper or levonorgestrel IUD for
birth control. Women who consent to participating in the study will be randomized to two
groups: one group will receive 2% lidocaine gel placed in the cervix prior to IUD placement
and the other group will receive a placebo inert gel. The primary objective of this study is
to compare the pain scores on a 10cm visual analogue scale in the two groups after tenaculum
placement (placing an instrument on the cervix to stabilize it), uterine sounding (measuring
of the uterus) and at speculum removal; these are standard procedures during IUD insertion.
Secondary outcomes include provider assessment of the patient's pain, patient's level of
satisfaction with the insertion, and whether any adverse events such as nausea/vomiting,
fainting, or IUD insertion failure occurred.
contraception used by approximately 8% of women in the developed world. In the United
States, historically candidates for IUDs were monogamous, parous women. Recent research has
shown that both copper and levonorgestrel IUD use is safe and effective in nulliparous
women. Nulliparous and parous women can experience significant amounts of pain during IUD
insertion. Concerns about insertional pain could be a barrier to IUD initiation women and
their healthcare providers.
This study will recruit women at either the Family Planning Clinic or the offices of
Columbia University Family Planning Practice who desire the copper or levonorgestrel IUD for
birth control. Women who consent to participating in the study will be randomized to two
groups: one group will receive 2% lidocaine gel placed in the cervix prior to IUD placement
and the other group will receive a placebo inert gel. The primary objective of this study is
to compare the pain scores on a 10cm visual analogue scale in the two groups after tenaculum
placement (placing an instrument on the cervix to stabilize it), uterine sounding (measuring
of the uterus) and at speculum removal; these are standard procedures during IUD insertion.
Secondary outcomes include provider assessment of the patient's pain, patient's level of
satisfaction with the insertion, and whether any adverse events such as nausea/vomiting,
fainting, or IUD insertion failure occurred.
Inclusion Criteria:
- Self-select either a Paragard or Mirena IUD and are appropriate for insertion as
determined by their provider
- Age 18-45
- Speak English or Spanish
Exclusion Criteria:
- Lidocaine allergy
- First trimester abortion or miscarriage in the previous six weeks
- Second trimester abortion or miscarriage in the previous 12 weeks
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