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Clinical Trials/NCT01207401
NCT01207401
Completed
Not Applicable

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

Northwestern University1 site in 1 country50 target enrollmentJuly 2010

Overview

Phase
Not Applicable
Intervention
Lidocaine
Conditions
Pain Control for Intrauterine Device Insertions
Sponsor
Northwestern University
Enrollment
50
Locations
1
Primary Endpoint
Median Visual Analogue Score Measuring Pain
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
July 2010
End Date
February 2011
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jessica Kiley

Assistant Professor

Northwestern University

Eligibility Criteria

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

Arms & Interventions

Paracervical Block

Intervention: Lidocaine

Outcomes

Primary Outcomes

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

Study Sites (1)

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