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

Early Phase 1

Completed

• Conditions: Pain
• Interventions: Drug: Placebo; Drug: Lidocaine

• Registration Number: NCT01445756
• Lead Sponsor: University of Wisconsin, Madison

Brief 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.

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.

Study Timeline

• Study Start: 2010-07
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Study First Submitted: 2011-08-23
• Study First Submitted QC: 2011-10-03
• Study First Posted: 2011-10-04
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-25
• Last Update Posted: 2014-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo
Topical Lidocaine	Lidocaine	Topical Lidocaine

Primary Outcome Measures

Name	Time	Method
Change in pain level from no Lidocaine administered to after Lidocaine is administered	Pain assessments prior to procedure, immediately after procedure, and 10 minutes after the procedure	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.

Trial Locations

Locations (1)

University Health Services Women's Care Clinic; 🇺🇸 Madison, Wisconsin, United States