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

NCT ID: NCT01534520

Last Updated: 2016-12-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2013-05-31

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.

Conditions

Pain

Keywords

Intrauterine Device; Pain; Lidocaine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Group 1: Intravaginal 2% lidocaine gel

Intravaginal insertion of 4mL of 2% lidocaine gel

Group Type: EXPERIMENTAL

Lidocaine

Intervention Type: DRUG

Intravaginal insertion of 4mL 2% lidocaine gel

Group 2: Intravaginal placebo gel

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

KY Jelly

Interventions

Lidocaine

Intravaginal insertion of 4mL 2% lidocaine gel

Intervention Type: DRUG

Placebo

KY Jelly

Intervention Type: DRUG

Other Intervention Names

Lidocaine Jelly; Lidocaine Hydrochloride; K-Y Jelly; water based lubricant

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

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Society of Family Planning

OTHER

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Sharon Achilles

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rachel B Rapkin, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

Magee-Womens Hospital

Pittsburgh, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 27500351 (View on PubMed)

Other Identifiers

SFP-RBR001

Identifier Type: -

Identifier Source: org_study_id