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Topical Lidocaine for Pain Control With Intrauterine Device (IUD) Insertion

This study is currently recruiting participants.
Verified September 2011 by University of Wisconsin, Madison
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01445756
First received: August 23, 2011
Last updated: October 3, 2011
Last verified: September 2011
History of Changes
  Purpose

Intrauterine contraception is a very effective, long term, reversible form of birth control, and is increasingly used in young, nulliparous patients. However, there is potential for pain with insertion of an Intrauterine Device (IUD) - particularly in patients without a previous history of vaginal delivery. The potential pain associated with insertion is often a significant barrier for patients when choosing and IUD for contraception. Several methods of pain control have been studied, but none have been shown to reduce pain at time of insertion. Our research question is to determine if 2% topical lidocaine gel, instilled into the cervical canal, will reduce maximum pain at time of insertion of a popular IUD (Mirena Intrauterine System) in young, nulliparous patients. This will be studied in a randomized, double-blind placebo-controlled trial.


Condition Intervention Phase
Pain
 Drug: Lidocaine
Drug: Placebo
 Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Health Services Research
Official Title: Topical Lidocaine for Pain Control With IUD Insertion: A Randomized Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Change in pain level from no Lidocaine administered to after Lidocaine is administered [ Time Frame: Pain assessments prior to procedure, immediately after procedure, and 10 minutes after the procedure ] [ Designated as safety issue: No ]
    The investigators plan to engage 40 patients in this study, and will ask each to fill out a questionnaire that covers age, ethnicity, pregnancy history, reason for IUD insertion and recent medication use. Patients will be asked to assess their pain on 3 separate occasions during the visit, by marking an X on a Visual Analog Scale. Providers will also be asked to fill out a questionnaire covering their experience with the interventions as well as their assessment of the patients' pain during the procedures.


Estimated Enrollment: 40
Study Start Date: July 2010
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Topical Lidocaine
Topical Lidocaine
 Drug: Lidocaine
During the procedure (placement of the IUD), 1ml of gel will be applied to the anterior lip of the cervix. After 1 minute of waiting, a tenaculum will be placed to steady the cervix. The catheter will be introduced into the cervical canal, past the external os and 1-1.5ml of gel will be placed into the canal. After another minute, the IUD will be placed in the standard fashion.
Other Name: Lidocaine
Placebo Comparator: Placebo
Placebo
 Drug: Placebo
Placebo; no topical lidocaine administered
Other Name: No intervention

Detailed Description:

The investigators research question is to determine if 2% topical lidocaine gel, instilled into the cervical canal, will reduce maximum pain at time of insertion of a popular IUD (Mirena Intrauterine System) in young, nulliparous patients. This will be studied in a randomized, double-blind placebo-controlled trial.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Must be at least 18 years old

Exclusion Criteria:

  • Age <18
  • Non-English speaking
  • Illiterate
  • History of pregnancy with delivery >20 weeks
  • History of prior IUD insertion or attempt
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01445756

Locations
United States, Wisconsin
University Health Services Women's Care Clinic Recruiting
Madison, Wisconsin, United States, 53715
Contact: Mary Landry, MD     608-265-5615     mslandry@uhs.wisc.edu    
Sub-Investigator: Mary Landry, MD            
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Mary Landry, MD University of Wisconsin Health Services
  More Information

No publications provided

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01445756     History of Changes
Other Study ID Numbers: H-2010-0062
Study First Received: August 23, 2011
Last Updated: October 3, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:
Intrauterine Device

Additional relevant MeSH terms:
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
 Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 23, 2013