Paracervical Block Before Intrauterine Device (IUD) Insertion

Not Applicable

Completed

• Conditions: Pain Control for Intrauterine Device Insertions
• Interventions: Drug: Lidocaine

• Registration Number: NCT01207401
• Lead Sponsor: Northwestern University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-09-21
• Study First Submitted QC: 2010-09-21
• Study First Posted: 2010-09-22
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Results First Submitted: 2012-07-25
• Status Verified: 2013-05
• Results First Submitted QC: 2013-05-02
• Last Update Submitted: 2013-05-02
• Results First Posted: 2013-06-10
• Last Update Posted: 2013-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Paracervical Block	Lidocaine	-

Primary Outcome Measures

Name	Time	Method
Median Visual Analogue Score Measuring Pain	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

Trial Locations

Locations (1)

Northwestern Medical Faculty Foundation or Prentice Ambulatory Care Clinic; 🇺🇸 Chicago, Illinois, United States