Topical Lidocaine on the Cervix and Intra-Cervical Prior to Insertion of Intrauterine Devices

Contraception Clinical Trial

— 10-053  

Official title:

Topical Lidocaine on the Cervix and Intra-Cervical Prior to Insertion of Intrauterine Devices

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01192490
• Other study ID #: 00002301
• Status: Recruiting
• Phase: N/A
• First received: August 26, 2010
• Last updated: June 15, 2011
• Start date: August 2010
• Est. completion date: December 2012

Study information

• Verified date: June 2011
• Source: University of Tennessee
• Contact: Ben Moore, MD
• Phone: 423-778-7515
• Email: benatmc[@]hotmail.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: December 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Contraception

Intervention

Drug:
• Lidocaine
5cc of 2% Lidocaine gel will be placed on the cervix and intra-cervically prior to placement of a Mirena
• Lubricant
KY Gel will be placed on the cervix and intra-cervically prior to placement of the Mirena

Locations

Country	Name	City	State
United States	University of Tennessee Chattanooga Department of Obstetrics and Gynecology	Chattanooga	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
University of Tennessee

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No