Clinical trial NCT01292447: A Trial of 2% Lidocaine Gel for Intrauterine Device (IUD) Insertion
Official title: A Randomized Controlled Trial of 2% Lidocaine Gel for IUD Insertion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: Pain measurement
Intrauterine devices
Lidocaine
Lead sponsor: Women and Infants Hospital of Rhode Island
Sponsor class: OTHER
Collaborators: name: Society of Family Planning
First posted: 2011-02-09
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Mean Pain Score During IUD Insertion
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: Women's Primary Care Center/Women and Infants' Hospital
state: Rhode Island
city: Providence
country: United States
facility: Womens Primary Care Center
state: Rhode Island
Study officials:
affiliation: Women and Infants Hospital of Rhode Island
name: Rebecca H Allen, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Allen RH, Raker C, Goyal V. Higher dose cervical 2% lidocaine gel for IUD insertion: a randomized controlled trial. Contraception. 2013 Dec;88(6):730-6. doi: 10.1016/j.contraception.2013.07.009. Epub 2013 Aug 1.