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

NCT01534520 | Completed Results DMC

• 1 other identifier: SFP-RBR001
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

Intrauterine Device; Pain; Lidocaine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• To Evaluate Patient Experience of Self-inserting the Intravaginal Study Gel Prior to IUD

  After inserting the gel but prior to IUD insertion

• Percentage of IUDs Considered by Physicians Easy to Insert

  Directly after IUD insertion

• Need for Pain Medication up to 7 Days

  7 days post-insertion

Study Arms (2)

Group 1: Intravaginal 2% lidocaine gel

EXPERIMENTAL

Intravaginal insertion of 4mL of 2% lidocaine gel

Drug: Lidocaine

Group 2: Intravaginal placebo gel

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Lidocaine DRUG

Intravaginal insertion of 4mL 2% lidocaine gel

Also known as: Lidocaine Jelly, Lidocaine Hydrochloride

Group 1: Intravaginal 2% lidocaine gel

Placebo DRUG

KY Jelly

Also known as: K-Y Jelly, water based lubricant

Group 2: Intravaginal placebo gel

Eligibility Criteria

• Age: 14 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• Society of Family Planning: collaborator

Study Sites (1)

Magee-Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

• 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.

  PMID: 27500351 DERIVED

MeSH Terms

Conditions

Pain

Interventions

Lidocaine; K-Y jelly

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Dionne Best
• Organization: UPittsburgh

dbest@upmc.edu

412-641-5496

Study Officials

• Rachel B Rapkin, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 13, 2012
• First Posted: February 16, 2012
• Study Start: June 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: December 22, 2016
• Results First Posted: December 22, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)