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

Self-administered Intravaginal 2% Lidocaine Gel Prior to Intrauterine Device Insertion in Nulliparous Women: a Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: Lidocaine; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Magee-Womens Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 55 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1: Intravaginal 2% lidocaine gel; Intravaginal insertion of 4mL of 2% lidocaine gel	Drug: Lidocaine; Intravaginal insertion of 4mL 2% lidocaine gel; Other Names: Lidocaine Hydrochloride; Lidocaine Jelly
Placebo Comparator: Group 2: Intravaginal placebo gel; Intravaginal insertion of 4mL of placebo gel ( K-Y Jelly)	Drug: Placebo; KY Jelly; Other Names: K-Y Jelly; water based lubricant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain From Baseline to IUD Insertion	To assess change in pain from baseline to IUD insertion measured on a visual analog scale (VAS) from 0 mm (no pain) to 100 mm (worst pain in patient's life). This pain assessment was prior to (baseline) and at the time of IUD insertion following vaginal self-administration of study gel (either 2% lidocaine gel or placebo gel).	change in pain score from baseline (before IUD insertion) to time of IUD insertion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To Evaluate Patient Experience of Self-inserting the Intravaginal Study Gel Prior to IUD	Number of participants who rated self-application of study gel as "some what easy" or "very easy" on Likert scale	After inserting the gel but prior to IUD insertion
Percentage of IUDs Considered by Physicians Easy to Insert	The physician who conducted the study visit and IUD insertion was asked about the difficulty/ease in placing the IUD immediately following the procedure and the percentage of IUD insertions considered to be "easy" was calculated for each study group.	Directly after IUD insertion
Need for Pain Medication up to 7 Days	Number of women taking pain medication for at least one day following IUD insertion	7 days post-insertion

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: Society of Family Planning
• Investigators: Principal Investigator: Rachel B Rapkin, MD, University of Pittsburgh

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: February 13, 2012
• First Submitted That Met QC Criteria: February 13, 2012
• First Posted (Estimate): February 16, 2012

Study Record Updates

• Last Update Posted (Estimate): December 22, 2016
• Last Update Submitted That Met QC Criteria: October 27, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Pain; Intrauterine Device; Lidocaine
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: SFP-RBR001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No