Intracervical Lidocaine Gel for IUD Insertional Pain
Condition: Pain
Study type: Interventional

Summary: 
      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
    

Detailed description: 
      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.
    

Intervention name(s): 2% lidocaine gel; placebo
Intervention type(s): Drug; Other
Intervention description(s): Participants, after informed consent, will be randomized in a 1:1 ratio to the inert gel group or the intervention group. In the intervention group, after tenaculum placement, a Q-tip soaked in approximately 1mL of 2% lidocaine gel will be placed in the cervix up to the level of the internal cervical os. The Q-tip will be held there for 1 minute and then be removed. We will repeat the same procedure in the control group with an inert gel similar in appearance, color and consistency to the lidocaine gel.
Both the patient and the provider will be blinded to which gel was received. The research assistant will place the gel from its labeled tube into the unlabeled sterile tube in another room.; Participants, after informed consent, will be randomized in a 1:1 ratio to the inert gel group or the intervention group. In the intervention group, after tenaculum placement, a Q-tip soaked in approximately 1mL of 2% lidocaine gel will be placed in the cervix up to the level of the internal cervical os. The Q-tip will be held there for 1 minute and then be removed. We will repeat the same procedure in the control/placebo group with an inert gel similar in appearance, color and consistency to the lidocaine gel.
Both the patient and the provider will be blinded to which gel was received. The research assistant will place the gel from its labeled tube into the unlabeled sterile tube in another room.
Other intervention name(s): surgilube
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Supportive Care
Keywords: IUD; Lidocaine gel