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Completed

NCT Number: NCT01292447

A Trial of 2% Lidocaine Gel for Intrauterine Device (IUD) Insertion

The intrauterine device (IUD) is a long-acting, highly effective, reversible contraceptive that may be underutilized due to fear of pain during insertion. Although providers frequently prescribe non-steroidal anti-inflammatory drugs (NSAIDs) for IUD insertion, there is no evidence for any pain reduction. In fact, no interventions evaluated in randomized controlled trials have been shown to be effective in reducing pain during IUD insertion. While many women tolerate IUD insertion well, others have moderate to severe pain. This double-blind randomized controlled trial of 150 women aims to estimate the efficacy of intracervical 2% lidocaine gel compared to placebo (KY jelly) to reduce IUD insertion pain. Our hypothesis is that women who are treated with 2% lidocaine gel prior to IUD insertion will have reduced pain as measured on a 0 mm to 100 mm Visual Analog Scale (VAS). We will be able to detect a 15 mm difference on the VAS with our sample size. Other data to be collected include information regarding age, BMI, obstetric history, lactation status, time since pregnancy or delivery, last menstrual period, history of cervical conization, anxiety levels, anticipated pain levels, insertion characteristics (time, difficulty, complications), side effects, and satisfaction with pain control. If 2% lidocaine gel is effective, then a viable, easily administered option for pain control will be available to providers and patients.

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Key information

Age range

18 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Women's Primary Care Center/Women and Infants' Hospital, Providence, Rhode Island, United States

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • plans for IUD insertion for contraception or abnormal uterine bleeding;
  • 18 to 49 years of age;
  • reached more than 6 weeks postpartum or 2 weeks postabortion if recently pregnant;
  • no prior IUD use;
  • not taken analgesics or anxiolytics in the previous 24 hours;
  • not taken misoprostol prior to IUD insertion;
  • the ability and are willing to give informed consent;
  • speaks English or Spanish.

Exclusion criteria

  • any contraindication to IUD placement;
  • allergy to lidocaine or sensitivities to components of the lidocaine or placebo gel;
  • chronic narcotic/benzodiazepine/barbiturate use within the past year.

Treatment and study plan

2% lidocaine gel

Drug

120mg lidocaine x 1

Placebo Gel

Drug

Inert gel x 1

Primary outcomes

  1. Mean Pain Score During IUD Insertion

    Time frame: Day 1

    0 to 100 mm visual analog scale, higher values represent more pain.

Sponsors and collaborators

Lead sponsor

Women and Infants Hospital of Rhode Island

Other

Collaborators

  • Society of Family Planning

Registry information

Official study title

A Randomized Controlled Trial of 2% Lidocaine Gel for IUD Insertion

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Feb 9, 2011
Registry last updated
Sep 2, 2020

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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