Recruiting

Lidocaine

Sponsor:

University of Tennessee

Code:

NCT01192490

Conditions

Contraception

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Accepted

Interventions

Lidocaine

Lubricant

Study Details

Brief 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).

Conditions

Contraception

Study ID

NCT01192490

Start date

Aug, 2010

Status verified date

Jun, 2011

Completion date

Dec, 2012

Anticipated

Primary completion date

Sep, 2012

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Accepted

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

Enrollment

210 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Lidocaine Arm

This arm will receive intracervical and cervical lidocaine prior to placement of a Mirena.

placebo comparator: Lubricant

Subjects in this arm will receive KY gel intracervically and on the cervix prior to placement of a Mirena.

Interventions

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

Primary outcome measure

  • Determine if topical lidocaine intra-cervically and on the cervix decreases the pain associated with insertion of a Mirena® (levonorgestrel intrauterine device). [ Time Frame: 2-3yrs ]

Central Contacts and Locations

Central contacts

Ben Moore, MD

423-778-7515benatmc@hotmail.com

Brett Bryant, MD

423-778-7515bryant_brett@hotmail.com

Locations

University of Tennessee Chattanooga Department of Obstetrics and Gynecology

Recruiting

Chattanooga, Tennessee, United States, 37403

Contacts

Ben Moore, MD

423-778-2580benatmc@hotmail.com

Brett Bryant, MD

423-778-7515brett_bryant@hotmail.com

Principal Investigator:

Kirk Brody, MD

More Information

Sponsor

University of Tennessee

Last update posted

Jun 16, 2011

Last verified

Jun, 2011

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Tennessee on 2011-06-16.