Paracervical Block Before Intrauterine Device (IUD) Insertion

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jessica Kiley, Northwestern University
ClinicalTrials.gov Identifier:
NCT01207401
First received: September 21, 2010
Last updated: May 2, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
Pain Control for Intrauterine Device Insertions
Drug: Lidocaine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pain Control for Intrauterine Device Insertion: A Randomized Trial of 1% Lidocaine Paracervical Block

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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


Enrollment: 50
Study Start Date: July 2010
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Paracervical Block Drug: Lidocaine
1% Lidocaine
No Intervention: No Paracervical Block

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  • Use of misoprostol within 24 hours prior to IUD insertion
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01207401

Locations
United States, Illinois
Northwestern Medical Faculty Foundation or Prentice Ambulatory Care Clinic
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Jessica Kiley, MD MPH Northwestern University
  More Information

No publications provided

Responsible Party: Jessica Kiley, Assistant Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT01207401     History of Changes
Other Study ID Numbers: STU00020958
Study First Received: September 21, 2010
Results First Received: July 25, 2012
Last Updated: May 2, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
intrauterine device
local anesthetic

Additional relevant MeSH terms:
Lidocaine
Anesthetics
Anesthetics, Local
Anti-Arrhythmia Agents
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Sodium Channel Blockers
Therapeutic Uses
Voltage-Gated Sodium Channel Blockers

ClinicalTrials.gov processed this record on October 23, 2014