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

NCT01192490 | Unknown DMC

• 1 other identifier: 00002301
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Lidocaine Arm

EXPERIMENTAL

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

Drug: Lidocaine

Lubricant

PLACEBO COMPARATOR

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

Drug: Lubricant

Interventions

Lidocaine DRUG

5cc of 2% Lidocaine gel will be placed on the cervix and intra-cervically prior to placement of a Mirena

Also known as: Mirena

Lidocaine Arm

Lubricant DRUG

KY Gel will be placed on the cervix and intra-cervically prior to placement of the Mirena

Also known as: KY gel

Lubricant

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Tennessee: lead

Study Sites (1)

University of Tennessee Chattanooga Department of Obstetrics and Gynecology

Chattanooga, Tennessee, 37403, United States

RECRUITING

MeSH Terms

Interventions

Lidocaine; Levonorgestrel; Lubricants

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Norgestrel; Norpregnenes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Specialty Uses of Chemicals; Chemical Actions and Uses

Study Officials

• Kirk Brody, MD

  University of Tennessee Chattanooga Department of Obstetrics and Gynecology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ben Moore, MD

CONTACT

423-778-7515; benatmc@hotmail.com

Brett Bryant, MD

CONTACT

423-778-7515; bryant_brett@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 26, 2010
• First Posted: September 1, 2010
• Study Start: August 1, 2010
• Primary Completion: September 1, 2012
• Study Completion: December 1, 2012
• Last Updated: June 16, 2011

Record last verified: 2011-06

Locations

US (1)