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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Society of Family Planning
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01534520
First received: February 13, 2012
Last updated: May 22, 2013
Last verified: May 2013
  Purpose

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 Intervention
Pain
Drug: Lidocaine
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Self-administered Intravaginal 2% Lidocaine Gel Prior to Intrauterine Device Insertion in Nulliparous Women: a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • To assess change in pain from baseline to IUD insertion as determined by 100mm visual analog scale (VAS) for self-administered intravaginal 2% lidocaine gel as compared to placebo gel. [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate patient acceptability of self-inserting the intravaginal study gel prior to IUD [ Time Frame: One year ] [ Designated as safety issue: No ]
  • To measure ease of IUD insertion as reported by physicians [ Time Frame: One year ] [ Designated as safety issue: No ]

Estimated Enrollment: 64
Study Start Date: June 2012
Estimated Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Intravaginal insertion of 5mL placebo gel
Drug: Placebo
KY Jelly
Experimental: Study Drug
Intravaginal insertion of 5mL 2% lidocaine gel
Drug: Lidocaine
Intravaginal insertion of 5mL 2% lidocaine gel
Other Names:
  • Lidocaine Jelly
  • Lidocaine Hydrochloride

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

Ages Eligible for Study:   14 Years to 55 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01534520

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

No publications provided

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01534520     History of Changes
Other Study ID Numbers: SFP-RBR001
Study First Received: February 13, 2012
Last Updated: May 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Intrauterine Device
Pain
Lidocaine

Additional relevant MeSH terms:
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 01, 2014