Cervical Lidocaine for Intrauterine Device Insertion Pain

Study Overview
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Brief Summary
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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
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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

Official Title
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Randomized Controlled Trial of Cervical Lidocaine for Intrauterine Device Insertion Pain

Conditions
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Pain

Intervention / Treatment
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* Drug: 2% lidocaine gel
* Drug: Water based lubricant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18-45 yrs selecting intrauterine device contraception able and willing to consent Exclusion Criteria: non-English speaking current intrauterine device use expulsion of intrauterine device within 2 weeks allergy to lidocaine or water based lubricant

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2% Lidocaine gel<br>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 | Drug: 2% lidocaine gel<br>* 3-5cc of 2% lidocaine gel will be applied to the lip of the cervix and within the endocervical canal prior to Intrauterine device insertion<br>* Other names: Lidocaine;|
| Placebo Comparator: Water based lubricant<br>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 | Drug: Water based lubricant<br>* 3-5cc of water based lubricant will be applied to the lip of the cervix and within the endocervical canal prior to intrauterine device insertion<br>* Other names: KY gel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Score Assessed 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) | Immediately following IUD insertion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intrauterine device, pain, lidocaine gel