Patient-Applied Pretreatment Analgesia for Intrauterine Device Placement

Study Overview
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Brief Summary
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The goal of this clinical trial is to perform a pilot study looking at the benefit of topical anesthetic application to the cervix by tampon prior to intra-uterine device insertion. The main question it aims to answer are: Does patient tampon-applied local anesthetic prior to insertion of an intrauterine device (IUD) reduce procedural duration? Does patient tampon-applied local anesthetic prior to insertion of an intrauterine device (IUD) reduce pain and improve patient perceptions of the procedure? Participants will place a tampon after dipping the tampon into the study-supplied medication (aqueous lidocaine or saline). Researchers will compare treatment and control groups to see if there is any difference in procedure time, difficulty or patient perceptions.

Detailed Description
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This Pilot Randomized Double Blind Clinical Trial study will assess the effectiveness of patient-applied aqueous lidocaine via tampon as a pre-treatment prior to intra-uterine device placement. Subjects will apply the lidocaine or a saline placebo to the end of a standard tampon with a plastic applicator and then place the tampon 1 hour prior to the procedure. The tampon will be removed as the subject prepares for the procedure. The procedure team will measure the procedure time as well as the subject and provider impressions of the procedure. This data will be evaluated to compare the lidocaine to the control group.

Official Title
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Patient-Applied Pretreatment Analgesia for Intrauterine Device Placement

Conditions
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Contraception

Intervention / Treatment
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* Drug: Lidocaine topical
* Device: Tampon


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Request IUD insertion Age 18 or older Willingness to return for procedure after completing virtual study consent Exclusion Criteria: Known allergy to viscous lidocaine or tampons Current vaginal or cervical injury

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 54 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aqueous lidocaine<br>Subject issued 5 ml jar of aqueous 4% lidocaine and will dip tampon distal end into jar for 30 seconds prior to placement. | Drug: Lidocaine topical<br>* 4% aqueous solution<br>* Other names: Lidocaine hydrochloride topical solution, USP, 4%;Device: Tampon<br>* Tampon with plastic applicator provided<br>|
| Placebo Comparator: Saline<br>Subject issued 5 ml jar of sterile saline and will dip tampon distal end into jar for 30 seconds prior to placement. | Device: Tampon<br>* Tampon with plastic applicator provided<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure time | Time from uterine sounding to cutting strings (to allow for procedures where an IUD is removed prior to placing a new IUD) | Measured during procedure | 
| Patient-reported pain level | 0-10 Visual analog scale | Obtained immediately after the procedure prior to the patient leaving the clinic | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-reported satisfaction with procedure | 0 - 100% | Obtained immediately after the procedure prior to the patient leaving the clinic | 
| Patient-reported interest in subsequent procedure | Likert scale | Obtained immediately after the procedure prior to the patient leaving the clinic | 
| Provider-reported procedural difficulty | Likert scale | Obtained immediately after the procedure prior to the patient leaving the clinic | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Long-Acting Reversible Contraception