Clinical trial NCT01534520: Self-administered Intravaginal 2% Lidocaine Gel Prior to Intrauterine Device Insertion in Nulliparous Women
Official title: Self-administered Intravaginal 2% Lidocaine Gel Prior to Intrauterine Device Insertion in Nulliparous Women: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: Intrauterine Device
Pain
Lidocaine
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Society of Family Planning
First posted: 2012-02-16
Enrollment: 61
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Pain From Baseline to IUD Insertion
timeFrame: change in pain score from baseline (before IUD insertion) to time of IUD insertion
Secondary outcomes:
measure: To Evaluate Patient Experience of Self-inserting the Intravaginal Study Gel Prior to IUD
timeFrame: After inserting the gel but prior to IUD insertion
measure: Percentage of IUDs Considered by Physicians Easy to Insert
timeFrame: Directly after IUD insertion
measure: Need for Pain Medication up to 7 Days
timeFrame: 7 days post-insertion
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Magee-Womens Hospital
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Rachel B Rapkin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rapkin RB, Achilles SL, Schwarz EB, Meyn L, Cremer M, Boraas CM, Chen BA. Self-Administered Lidocaine Gel for Intrauterine Device Insertion in Nulliparous Women: A Randomized Controlled Trial. Obstet Gynecol. 2016 Sep;128(3):621-8. doi: 10.1097/AOG.0000000000001596.