Text Size

Paracervical Block Before IUD Insertion

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Northwestern University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Northwestern University
ClinicalTrials.gov Identifier:
NCT01207401
First received: September 21, 2010
Last updated: NA
Last verified: September 2010
History: No changes posted
  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:

U.S. FDA Resources

Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Pain score on a VAS [ Time Frame: 1) Speculum placement 2) Tenaculum placement 3) Administration of paracervical block (if subject is in this arm) 4) IUD insertion 5) Five minutes after IUD insertion ] [ Designated as safety issue: No ]
    To compare pain with intrauterine device insertion in women who 1)receive 1% lidocaine paracervical block prior to intrauterine device insertion and, 2)do not receive no local anesthetic


Estimated Enrollment: 50
Study Start Date: July 2010
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: July 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01207401

Locations
United States, Illinois
Northwestern Medical Faculty Foundation or Prentice Ambulatory Care Clinic Recruiting
Chicago, Illinois, United States, 60611
Contact: Sheila Krishnan, MD MPH         s-krishnan@md.northwestern.edu    
Sub-Investigator: Sheila Krishnan, MD MPH            
Sub-Investigator: Cassing Hammond, MD            
Sub-Investigator: Catherine Stika, MD            
Sub-Investigator: Deborah Wodell, APN            
Principal Investigator: Jessica Kiley, MD MPH            
Sponsors and Collaborators
Northwestern University
  More Information

No publications provided

Responsible Party: Jessica Kiley, Northwestern Medical Faculty Foundation
ClinicalTrials.gov Identifier: NCT01207401     History of Changes
Other Study ID Numbers: STU00020958
Study First Received: September 21, 2010
Last Updated: September 21, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
intrauterine device
local anesthetic

Additional relevant MeSH terms:
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
 Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 21, 2013