Cervical Lidocaine for Intrauterine Device Insertion Pain

Not Applicable

Completed

• Conditions: Pain
• Interventions: Drug: Water based lubricant; Drug: 2% lidocaine gel

• Registration Number: NCT01411995
• Lead Sponsor: Washington University School of Medicine

Brief Summary

The aim of this study is to evaluate intracervical lidocaine gel as a means to decrease pain associated with intrauterine device (IUD) insertion. They will be randomized to either placebo (inert water based lubricating gel) or 2% lidocaine gel to be placed intracervically via angio-catheter just before intrauterine device insertion. Anticipated pain scores will be assessed using a visual analog scale prior to insertion. Using the same pain scale, patients will again be asked at the end of the procedure to rate their pain.

Detailed Description

Double blind randomized controlled trial.

Primary outcome: Pain reported on Visual Analog Scale (VAS) Intervention: 2% lidocaine gel at the tenaculum site and intracervical prior to intrauterine device placement

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-08-03
• Study First Submitted QC: 2011-08-04
• Study First Posted: 2011-08-08
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Results First Submitted: 2016-01-12
• Status Verified: 2018-02
• Results First Submitted QC: 2018-02-09
• Last Update Submitted: 2018-02-09
• Results First Posted: 2018-03-09
• Last Update Posted: 2018-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

• age 18-45 yrs
• selecting intrauterine device contraception
• able and willing to consent

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Exclusion Criteria

• non-English speaking
• current intrauterine device use
• expulsion of intrauterine device within 2 weeks
• allergy to lidocaine or water based lubricant

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Water based lubricant	Water based lubricant	Women randomized to the placebo arm will receive a total of 3-5cc of water based lubricant at the tenaculum site and within the the endocervical canal
2% Lidocaine gel	2% lidocaine gel	Women randomized to the Lidocaine arm will receive a total of 3-5cc of 2% gel at the tenaculum site and within the endocervical canal

Primary Outcome Measures

Name	Time	Method
Pain Score Assessed Immediately Following IUD Insertion	Immediately following IUD insertion	Using a visual analog scale, women will report their level of pain pre-procedure, after tenaculum placement, and post-procedure (following IUD insertion).The entirety of the procedure should last no more than 5-10 minutes. The pain score is assessed at the 3 timepoints within that 10 minute window. No additional followup is required.; Range: 0-10 (0= no pain, 10=worst pain)

Trial Locations

Locations (1)

Division of Clinical Research at Washington University; 🇺🇸 Saint Louis, Missouri, United States