Paracervical Block Before Intrauterine Device (IUD) Insertion
Pain Control for Intrauterine Device Insertion: A Randomized Trial of 1% Lidocaine Paracervical Block
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2010
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2010
CompletedFirst Submitted
Initial submission to the registry
September 21, 2010
CompletedFirst Posted
Study publicly available on registry
September 22, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2011
CompletedResults Posted
Study results publicly available
June 10, 2013
CompletedJune 10, 2013
May 1, 2013
7 months
September 21, 2010
July 25, 2012
May 2, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Median Visual Analogue Score Measuring Pain
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
Study Arms (2)
Paracervical Block
EXPERIMENTALNo Paracervical Block
NO INTERVENTIONInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Northwestern Medical Faculty Foundation or Prentice Ambulatory Care Clinic
Chicago, Illinois, 60611, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Sheila Krishnan Mody
- Organization
- University of California, San Diego
Study Officials
- PRINCIPAL INVESTIGATOR
Jessica Kiley, MD MPH
Northwestern University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
September 21, 2010
First Posted
September 22, 2010
Study Start
July 1, 2010
Primary Completion
February 1, 2011
Study Completion
February 1, 2011
Last Updated
June 10, 2013
Results First Posted
June 10, 2013
Record last verified: 2013-05