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

University of Wisconsin (UW)

Status and phase: Completed; Early Phase 1

Conditions: Pain

Treatments: Drug: Lidocaine; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01445756

H-2010-0062

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

Topical Lidocaine

Active Comparator group

Description:

Topical Lidocaine

Treatment:

Drug: Lidocaine

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo