Self-administered Intravaginal 2% Lidocaine Gel Prior to Intrauterine Device Insertion in Nulliparous Women (LIVIIN)

University of Pittsburgh

Status: Completed

Conditions: Pain

Treatments: Drug: Placebo; Drug: Lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT01534520

SFP-RBR001

Details and patient eligibility

About

This study is designed to evaluate if self-inserted intravaginal 2% lidocaine gel is effective at decreasing pain during intrauterine device insertion in nulliparous women.

Full description

Intrauterine devices (IUDs) are among the most effective forms of reversible contraception. Numerous studies demonstrate their safety and efficacy in nulliparous women, however, uptake of IUDs in this group is low. One of the major barriers to women obtaining IUDs is fear of pain during insertion, as studies do demonstrate that nulliparous women experience more pain than parous women during IUD insertion. Studies evaluating various methods for pain control during IUD insertion have shown conflicting results, leaving the question unanswered as to what is the best method to decrease pain during IUD insertion.

This study aims to evaluate a novel approach to pain control by having women self-insert lidocaine gel into the vagina at least 5 minutes prior to IUD insertion. This will overcome some of the barriers from other studies where there may not have been ample time for the lidocaine to take effect, while at the same time eliminating the need for women to have multiple speculum exams. Although this is a novel approach to administering an anesthetic, we believe women will be interested in any intervention that may potentially alleviate pain during IUD insertion.

If this study does demonstrate that pain is decreased with self-inserted lidocaine compared to placebo gel, this will potentially eliminate one large barrier to nulliparous women receiving IUDs. Increased uptake of highly effective contraception in nulliparous women is just one of the many steps necessary towards decreasing unintended pregnancy.

Enrollment: 61 patients

Sex: Female

Ages: 14 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Nulliparous, as defined in this study as no history of pregnancy ≥ 24 weeks gestational age
• Desires insertion of either levonorgestrel-releasing IUD (LNG-IUD) or copper T380A IUD (Cu-IUD)
• No history of pregnancy in the last 6 weeks
• Able to provide written informed consent in English and comply with all study procedures

Exclusion criteria

• Known allergy or hypersensitivity to lidocaine or other amino amide local anesthetics
• Prior failed IUD insertion
• Prior IUD use
• Use of narcotic or benzodiazepine medication within the last 24 hours
• U.S. Centers for Disease Control Medical Eligibility Criteria (MEC) category 3 or 4 classification for use of an IUD
• Positive pregnancy test or reasonable risk of pregnancy due to unprotected heterosexual intercourse since the last menstrual period

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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61 participants in 2 patient groups, including a placebo group

Group 1: Intravaginal 2% lidocaine gel

Experimental group

Description:

Intravaginal insertion of 4mL of 2% lidocaine gel

Treatment:

Drug: Lidocaine

Group 2: Intravaginal placebo gel

Placebo Comparator group

Description:

Intravaginal insertion of 4mL of placebo gel ( K-Y Jelly)

Treatment:

Drug: Placebo