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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01292447
• Other study ID #: 10-0084
• Status: Completed
• Phase: N/A
• Start date: February 2011
• Est. completion date: February 2013

Study information

• Verified date: August 2020
• Source: Women and Infants Hospital of Rhode Island
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• 2% lidocaine gel
120mg lidocaine x 1
• Placebo gel
Inert gel x 1

Locations

Country	Name	City	State
United States	Women's Primary Care Center/Women and Infants' Hospital	Providence	Rhode Island
United States	Womens Primary Care Center	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Women and Infants Hospital of Rhode Island	Society of Family Planning

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Pain Score During IUD Insertion	0 to 100 mm visual analog scale, higher values represent more pain.	Day 1