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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by University of Tennessee.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Tennessee
ClinicalTrials.gov Identifier:
NCT01192490
First received: August 26, 2010
Last updated: June 15, 2011
Last verified: June 2011
  Purpose

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).


Condition Intervention
Contraception
Drug: Lidocaine
Drug: Lubricant

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Prevention
Official Title: Topical Lidocaine on the Cervix and Intra-Cervical Prior to Insertion of Intrauterine Devices

Resource links provided by NLM:


Further study details as provided by University of Tennessee:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 210
Study Start Date: August 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: KY gel

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01192490

Contacts
Contact: Ben Moore, MD 423-778-7515 benatmc@hotmail.com
Contact: Brett Bryant, MD 423-778-7515 bryant_brett@hotmail.com

Locations
United States, Tennessee
University of Tennessee Chattanooga Department of Obstetrics and Gynecology Recruiting
Chattanooga, Tennessee, United States, 37403
Contact: Ben Moore, MD    423-778-2580    benatmc@hotmail.com   
Contact: Brett Bryant, MD    423-778-7515    brett_bryant@hotmail.com   
Principal Investigator: Kirk Brody, MD         
Sub-Investigator: Benjamin Moore, MD         
Sub-Investigator: Joseph Bryant, MD         
Sub-Investigator: David Barker, MD         
Sponsors and Collaborators
University of Tennessee
Investigators
Principal Investigator: Kirk Brody, MD University of Tennessee Chattanooga Department of Obstetrics and Gynecology
  More Information

No publications provided

Responsible Party: Terry Williams, DO, University of Tennessee Chattanooga Department of Obstetrics and Gynecology
ClinicalTrials.gov Identifier: NCT01192490     History of Changes
Other Study ID Numbers: 00002301
Study First Received: August 26, 2010
Last Updated: June 15, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Lidocaine
Anesthetics
Anesthetics, Local
Anti-Arrhythmia Agents
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Sodium Channel Blockers
Therapeutic Uses
Voltage-Gated Sodium Channel Blockers

ClinicalTrials.gov processed this record on November 25, 2014