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

• ClinicalTrials.gov Identifier: NCT01534520
• Recruitment Status: Completed
• First Posted: February 16, 2012
• Results First Posted: December 22, 2016
• Last Update Posted: December 22, 2016
• Sponsor: University of Pittsburgh
• Collaborator: Society of Family Planning
• Information provided by (Responsible Party): Sharon Achilles, University of Pittsburgh

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Pain	Drug: Lidocaine; Drug: Placebo	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 61 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Self-administered Intravaginal 2% Lidocaine Gel Prior to Intrauterine Device Insertion in Nulliparous Women: a Randomized Controlled Trial
• Study Start Date: June 2012
• Actual Primary Completion Date: May 2013
• Actual Study Completion Date: May 2013

Arms and Interventions

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 Jelly; Lidocaine Hydrochloride
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

Outcome Measures

Primary Outcome Measures :

1. Change in Pain From Baseline to IUD Insertion [ Time Frame: change in pain score from baseline (before IUD insertion) to time of 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).

Secondary Outcome Measures :

1. To Evaluate Patient Experience of Self-inserting the Intravaginal Study Gel Prior to IUD [ Time Frame: After inserting the gel but prior to IUD insertion ]
   Number of participants who rated self-application of study gel as "some what easy" or "very easy" on Likert scale
2. Percentage of IUDs Considered by Physicians Easy to Insert [ Time Frame: Directly after IUD insertion ]
   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.
3. Need for Pain Medication up to 7 Days [ Time Frame: 7 days post-insertion ]
   Number of women taking pain medication for at least one day following IUD insertion

Eligibility Criteria

• Ages Eligible for Study: 14 Years to 55 Years (Child, Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

United States, Pennsylvania

Magee-Womens Hospital

Pittsburgh, Pennsylvania, United States, 15213

Sponsors and Collaborators

University of Pittsburgh

Society of Family Planning

Investigators

• Principal Investigator: Rachel B Rapkin, MD; University of Pittsburgh

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Sharon Achilles, Assistant Professor, University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT01534520
• Other Study ID Numbers: SFP-RBR001
• First Posted: February 16, 2012
• Results First Posted: December 22, 2016
• Last Update Posted: December 22, 2016
• Last Verified: October 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Sharon Achilles, University of Pittsburgh:

Intrauterine Device; Pain; Lidocaine

Additional relevant MeSH terms:

Lidocaine; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents; Anti-Arrhythmia Agents; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action