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

Not Applicable

Completed

• Conditions: Pain
• Interventions: Drug: 2% lidocaine gel; Drug: Placebo gel

• Registration Number: NCT01292447
• Lead Sponsor: Women and Infants Hospital of Rhode Island

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-01-24
• Study Start: 2011-02
• Study First Submitted QC: 2011-02-08
• Study First Posted: 2011-02-09
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Status Verified: 2020-08
• Results First Submitted: 2020-08-14
• Results First Submitted QC: 2020-08-31
• Last Update Submitted: 2020-08-31
• Results First Posted: 2020-09-02
• Last Update Posted: 2020-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study Group	2% lidocaine gel	Will receive placement of 2% lidocaine gel on ectocervix and in cervical canal prior to IUD placement.
Control Group	Placebo gel	Will receive placement of inert glycerin gel on ectocervix and in cervical canal prior to IUD placement.

Primary Outcome Measures

Name	Time	Method
Mean Pain Score During IUD Insertion	Day 1	0 to 100 mm visual analog scale, higher values represent more pain.

Trial Locations

Locations (2)

Womens Primary Care Center; 🇺🇸 Providence, Rhode Island, United States

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