Topical Lidocaine for Pain Control With Intrauterine Device (IUD) Insertion
Information source: University of Wisconsin, Madison
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain
Intervention: Lidocaine (Drug); Placebo (Drug)
Phase: Phase 0
Status: Completed
Sponsored by: University of Wisconsin, Madison Official(s) and/or principal investigator(s):
Mary Landry, MD, Principal Investigator, Affiliation: University of Wisconsin Health Services
Summary
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.
Clinical Details
Official title: Topical Lidocaine for Pain Control With IUD Insertion: A Randomized Controlled Trial
Study design: Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Health Services Research
Primary outcome: Change in pain level from no Lidocaine administered to after Lidocaine is administered
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
Minimum age: 18 Years.
Maximum age: 35 Years.
Gender(s): Female.
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
Locations and Contacts
University Health Services Women's Care Clinic, Madison, Wisconsin 53715, United States
Additional Information
Starting date: July 2010
Last updated: August 25, 2014
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