Topical Lidocaine on the Cervix and Intra-Cervical Prior to Insertion of Intrauterine Devices (10-053)

The hypothesis of this study is that topical cervical and intra-cervical lidocaine will decrease pain associated with the insertion of a Mirena® (levonorgestrel intrauterine device).

1. Primary Aim- Determine if topical lidocaine intra-cervically and on the cervix decreases the pain associated with insertion of a Mirena® (levonorgestrel intrauterine device).

Study Overview

• Status: Unknown
• Conditions: Contraception
• Intervention / Treatment: Drug: Lidocaine; Drug: Lubricant

Detailed Description

There have been multiple studies performed to determine a medication that will decrease the pain associated with intrauterine device insertion. These studies have tested the use of misoprostol as well as NSAIDS to determine if these decrease the pain associated with insertion. There has also been one small, poorly performed, study that tested the use of intracervical topical lidocaine prior to IUD insertion. Misoprostol and NSAIDS were found to be non-efficacious in decreasing pain. Topical lidocaine was shown to be effective, however, secondary to this being a poorly performed study, additional studies are needed. This study is to determine if topical lidocaine does indeed decrease the pain associated with insertion of the Mirena® (levonorgestrel intrauterine device).

This is a double blinded experimental study to determine whether or not topical lidocaine gel applied to the cervix and intra-cervically decreases pain associated with insertion of the Mirena® (levonorgestrel intrauterine device). Subjects will be randomized into two groups. One group will receive 2% lidocaine gel on the cervix and intra-cervically. The other group will receive a placebo, which will consist of KY being placed on the cervix and intra-cervically. After the Mirena® (levonorgestrel intrauterine device) is inserted, each subject's pain will be assessed by using a visual analog pain scale, and their response will be recorded on the information form. This pain scale will be assessed at the time of insertion, five minutes after insertion, and ten minutes after insertion. The only other study that researched the use of topical lidocaine prior to insertion of an IUD only recorded a pain scale at the time of insertion. Additional scores will be recorded at five and ten minutes to determine if pain is reduced in those time periods. These time periods have been chosen in order that all of this information can be recorded during a normal office visit. A visual analog pain scale is the scale included which measures pain on a scale of zero to ten with zero being no pain at all and ten being the worst pain of your life. This pain scale will be a scale ranging from zero to ten with faces depicting the amount of pain involved for each score. Since there will be different physicians placing the intrauterine devices, there will be a protocol on how to perform the insertion in an attempt to make all insertions as uniform as possible. A copy of this protocol has been included.

• Study Type: Interventional
• Enrollment (Anticipated): 210
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Chattanooga, Tennessee, United States, 37403
      • Recruiting
      • University of Tennessee Chattanooga Department of Obstetrics and Gynecology
      • Sub-Investigator: David Barker, MD
      • Contact: Ben Moore, MD; Phone Number: 423-778-2580; Email: benatmc@hotmail.com
      • Contact: Brett Bryant, MD; Phone Number: 423-778-7515; Email: brett_bryant@hotmail.com
      • Principal Investigator: Kirk Brody, MD
      • Sub-Investigator: Benjamin Moore, MD
      • Sub-Investigator: Joseph Bryant, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Any subject receiving a Mirena® (levonorgestrel intrauterine device) for standard indications.
2. Subjects who received nonsteroidal anti-inflammatory drugs (NSAIDS) will not be excluded.

Exclusion Criteria:

1. Subjects do not desire to be involved in the study
2. Subjects who have taken narcotics.
3. If the Mirena® (levonorgestrel intrauterine device) is not able to be successfully placed.
4. If cervical dilation is required, these subjects will be placed in a separate subset and will be reported on separately.
5. Subject has allergy to lidocaine.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lidocaine Arm; This arm will receive intracervical and cervical lidocaine prior to placement of a Mirena.	Drug: Lidocaine; 5cc of 2% Lidocaine gel will be placed on the cervix and intra-cervically prior to placement of a Mirena; Other Names: Mirena
Placebo Comparator: Lubricant; Subjects in this arm will receive KY gel intracervically and on the cervix prior to placement of a Mirena.	Drug: Lubricant; KY Gel will be placed on the cervix and intra-cervically prior to placement of the Mirena; Other Names: KY gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine if topical lidocaine intra-cervically and on the cervix decreases the pain associated with insertion of a Mirena® (levonorgestrel intrauterine device).	In order to analyze the data, pain scores will be stratified into three different categories. These categories will be as follows: visual analog scale (VAS) score of 0-2, VAS score of 2-4, VAS score of 5 and greater. This will allow an odds ratio to be calculated and the use of a Chi Square analysis.	2-3yrs

Collaborators and Investigators

• Sponsor: University of Tennessee
• Investigators: Principal Investigator: Kirk Brody, MD, University of Tennessee Chattanooga Department of Obstetrics and Gynecology

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Anticipated): September 1, 2012
• Study Completion (Anticipated): December 1, 2012

Study Registration Dates

• First Submitted: August 26, 2010
• First Submitted That Met QC Criteria: August 30, 2010
• First Posted (Estimate): September 1, 2010

Study Record Updates

• Last Update Posted (Estimate): June 16, 2011
• Last Update Submitted That Met QC Criteria: June 15, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• 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: 00002301