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

August 31, 2020 updated by: Rebecca H. Allen, MD, Women and Infants Hospital of Rhode Island

A Randomized Controlled Trial of 2% Lidocaine Gel for 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • Women's Primary Care Center/Women and Infants' Hospital
      • Providence, Rhode Island, United States, 02905
        • Womens Primary Care Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 49 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control Group
Will receive placement of inert glycerin gel on ectocervix and in cervical canal prior to IUD placement.
Drug: Placebo gel
Inert gel x 1
Experimental: Study Group
Will receive placement of 2% lidocaine gel on ectocervix and in cervical canal prior to IUD placement.
Drug: 2% lidocaine gel
120mg lidocaine x 1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Pain Score During IUD Insertion
Time Frame: Day 1
0 to 100 mm visual analog scale, higher values represent more pain.
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Women and Infants Hospital of Rhode Island

Collaborators

Society of Family Planning

Investigators

  • Principal Investigator: Rebecca H Allen, MD, MPH, Women and Infants Hospital of Rhode Island

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

January 24, 2011

First Submitted That Met QC Criteria

February 8, 2011

First Posted (Estimate)

February 9, 2011

Study Record Updates

Last Update Posted (Actual)

September 2, 2020

Last Update Submitted That Met QC Criteria

August 31, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-0084

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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