Paracervical Block Before Intrauterine Device (IUD) Insertion

May 2, 2013 updated by: Jessica Kiley, Northwestern University

Pain Control for Intrauterine Device Insertion: A Randomized Trial of 1% Lidocaine Paracervical Block

The purpose of this study is to evaluate if a paracervical block containing 1% lidocaine administered prior to IUD insertion reduces insertion pain. The hypothesis is that women receiving paracervical analgesia will experience less pain during IUD insertion than those who do not receive such analgesia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Medical Faculty Foundation or Prentice Ambulatory Care Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women age 18 -50 years
  • A negative urine pregnancy test and clinically unlikely to be pregnant
  • Seeking an intrauterine device for any indication
  • Willing and able to sign an informed consent in English

Exclusion Criteria:

  • History of a prior IUD successful insertion
  • Previous failed insertion of an IUD
  • Known copper allergy
  • Known levonorgestrel allergy
  • Known lidocaine allergy
  • Current cervicitis
  • Pelvic Inflammatory Disease (PID) within 3 months
  • Pregnancy within six weeks prior to IUD insertion
  • Uterine anomaly or distortion of the uterine cavity
  • Use of any other pain medication within 6 hours prior to IUD insertion
  • Use of misoprostol within 24 hours prior to IUD insertion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Paracervical Block
Drug: Lidocaine
1% Lidocaine
No Intervention: No Paracervical Block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Median Visual Analogue Score Measuring Pain
Time Frame: 1) Speculum placement 2) Tenaculum placement 3) Paracervical block administration(if subject is in this arm) 4) IUD insertion 5) Five minutes post procedure

We asked participants to report their pain score on visual analogue scale (0mm=no pain and 100mm=worse pain possible) at the following time points:

  1. Speculum placement
  2. Tenaculum placement
  3. Paracervical block administration(if subject is in this arm)
  4. IUD insertion
  5. Five minutes post procedure
1) Speculum placement 2) Tenaculum placement 3) Paracervical block administration(if subject is in this arm) 4) IUD insertion 5) Five minutes post procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Investigators

  • Principal Investigator: Jessica Kiley, MD MPH, Northwestern University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

September 21, 2010

First Submitted That Met QC Criteria

September 21, 2010

First Posted (Estimate)

September 22, 2010

Study Record Updates

Last Update Posted (Estimate)

June 10, 2013

Last Update Submitted That Met QC Criteria

May 2, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU00020958

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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