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Completed

NCT Number: NCT01311102

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

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Women's Health Care Clinic

Torrance, California, 90502, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women eligible for IUD insertion
  • Willing to give consent

Exclusion criteria

  • Allergy to lidocaine
  • Contraindications to IUD use

Treatment and study plan

Lidocaine

Drug

1.33 cc 2% liquid lidocaine

Other names: Lidocaine Hydrochloride, Xylocaine

normal saline

Drug

1.33cc normal saline

Other names: Sodium chloride

Primary outcomes

  1. Pain Scores During Overall IUD Placement

    Time frame: Before patient left the examination room at conclusion of procedure

    Pain score on 0-9 scale obtained just before the patient left the examination room; with 0 being "no pain" and 9 being "worst pain in life."

  2. Pain During Tenaculum Placement

    Time frame: Immediately following tenaculum placement

    Pain score on 0-9 scale for tenaculum placement (without anesthesia); with 0 being "no pain" and 9 being "worst pain in life." Taken to adjust for different pain thresholds among subjects

  3. Pain Measurement During Liquid Infusion/Sounding

    Time frame: Recorded at the end of the infusion

    After liquid infused into three parts of the endometrial cavity: in the lower one third, the middle, and at the top of the cavity. Pain was scored on a 0-9 scale; with 0 being "no pain" and 9 being "worst pain in life."

  4. Pain During IUD Placement

    Time frame: Immediately after IUD placement

    IUD was inserted following the manufacturer's instructions, and a pain score was immediately obtained. Pain was scored on 0-9 scale; with 0 being "no pain" and 9 being "worst pain in life."

Sponsors and collaborators

Lead sponsor

Women's Health Care Clinic, Torrance, California

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2008
Study completion
2012
First posted
Mar 9, 2011
Registry last updated
Feb 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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