Study of Local Anesthesia as a Method to Decrease IUD Insertion Related Pain

Study Overview
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Brief Summary
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Despite the high efficacy of intrauterine devices (IUDs), some women choose not to receive IUDs secondary to the pain associated with insertion. Nulliparous women may be especially susceptible to procedure-related pain from IUD insertion. This study will investigate the difference in perceived pain from IUD insertion, comparing local anesthesia to a placebo, among women who have not had a vaginal delivery before. The investigators anticipate that among women who have not had a previous vaginal delivery, the pain associated with IUD insertion will be significantly decreased after administration of local anesthesia.

Detailed Description
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The study will investigate the difference in perceived pain from IUD insertion, comparing paracervical block with lidocaine to a placebo (bacteriostatic saline) block, among nulliparous and functionally nulliparous women. The investigators plan a double-masked, placebo controlled, randomized clinical trial. The investigators anticipate that among patients who have not had a previous vaginal delivery, the pain associated with IUD insertion will be significantly decreased after administration of a 15 mL 1% lidocaine paracervical block compared to patients who receive 15 mL of bacteriostatic saline (placebo).

Official Title
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Paracervical Block With Lidocaine as a Modality to Decrease IUD Insertion Related Pain

Conditions
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IUD Insertion Complication, Pain Control

Intervention / Treatment
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* Drug: Lidocaine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Nulliparous and functionally nulliparous women receiving their first IUD. Functionally nulliparous women include those who have never had a prior vaginal delivery or who have never experienced previous significant cervical dilation (ie. women who have experienced miscarriages or abortions prior to 24 weeks gestation, and women who have had cesarean sections while not in active labor defined as <4 cm dilation). English speaking Exclusion Criteria: Presence of a Centers for Disease Control Medical Eligibility Criteria for Contraceptive Use category 3 or 4 precaution to a levonorgestrel IUD chronic narcotic use, current or past history of illegal drug use (excluding marijuana) allergy to lidocaine

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lidocaine<br>Paracervical block using 15 mL of 1 % lidocaine | Drug: Lidocaine<br> <br> |
| Placebo Comparator: Placebo<br>paracervical block using 15 mL of bacteriostatic saline | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain at time of IUD insertion | Differences in visual analog scale (VAS) measurements of perceived pain at the time of IUD deployment | During IUD insertion (no further follow up after patient leaves ofice) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain at other time points of pelvic exam | Intrapersonal and group differences in VAS measurements of expected pain and other time points | During other steps of pelvic exam up to 15b minutes after IUD inserted (no further follow up after patient leaves office) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intrauterine device, Paracervical block