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Paracervical Block Before Intrauterine Device (IUD) Insertion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01207401
Recruitment Status : Completed
First Posted : September 22, 2010
Results First Posted : June 10, 2013
Last Update Posted : June 10, 2013
Sponsor:
Information provided by (Responsible Party):
Jessica Kiley, Northwestern University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pain Control for Intrauterine Device Insertions Drug: Lidocaine Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pain Control for Intrauterine Device Insertion: A Randomized Trial of 1% Lidocaine Paracervical Block
Study Start Date : July 2010
Actual Primary Completion Date : February 2011
Actual Study Completion Date : February 2011

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Paracervical Block Drug: Lidocaine
1% Lidocaine
No Intervention: No Paracervical Block


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01207401


Locations
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United States, Illinois
Northwestern Medical Faculty Foundation or Prentice Ambulatory Care Clinic
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
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Principal Investigator: Jessica Kiley, MD MPH Northwestern University
More Information
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Responsible Party: Jessica Kiley, Assistant Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT01207401    
Other Study ID Numbers: STU00020958
First Posted: September 22, 2010    Key Record Dates
Results First Posted: June 10, 2013
Last Update Posted: June 10, 2013
Last Verified: May 2013
Keywords provided by Jessica Kiley, Northwestern University:
intrauterine device
local anesthetic
Additional relevant MeSH terms:
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Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
 Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action