The Impact of Pain Scores on Intrauterine Lidocaine Versus Normal Saline Infusion at the Time of IUD Placement
Condition: Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

Detailed description: 
      IUDs are the most frequently used method of reversible birth control. 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.

      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.
    

Intervention name(s): Lidocaine; Normal Saline
Intervention type(s): Drug; Drug
Intervention description(s): 1.33 cc 2% liquid lidocaine; 1.33cc normal saline
Other intervention name(s): Lidocaine Hydrochloride; Xylocaine; Sodium chloride
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Pain score; IUD placement