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

NCT01445756 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2014-08-26

No results posted yet for this study

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.

Conditions

Interventions

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.

DRUG

Placebo

Placebo; no topical lidocaine administered

Sponsors & Collaborators

  • University of Wisconsin, Madison

    lead OTHER

Principal Investigators

  • Mary Landry, MD · University of Wisconsin Health Services

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2011-06-30
Completion
2011-06-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01445756 on ClinicalTrials.gov