Paracervical Block Versus No Paracervical Block During IUD Insertion

Study Overview
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Brief Summary
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The purpose of this study is to compare the pain level and level of discomfort with paracervical block versus no analgesia in women who present to the University of Texas (UT) Physicians Obstetrics and Gynecology Continuity Clinic, The UT Physicians Women's Center, and the UT Physicians Women's Center- Bellaire for IUD insertion.

Official Title
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Paracervical Block Versus No Paracervical Block During IUD Insertion

Conditions
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Analgesia, IUD Insertion

Intervention / Treatment
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* Drug: Lidocaine
* Other: No analgesia
* Device: Intrauterine device (IUD)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women of reproductive age who present for an IUD insertion procedure at the University of Texas Physicians Obstetrics and Gynecology Continuity Clinic, The UT Physicians Women's Center, and the UT Physicians Women's Center- Bellaire for IUD insertion. Exclusion Criteria: Women with current pelvic inflammatory disease (PID) Women who are not good candidates for an IUD Patients who have a Lidocaine allergy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 52 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Paracervical block<br>Intrauterine device (IUD) placement with paracervical block with 1% lidocaine. | Drug: Lidocaine<br>* Intrauterine device (IUD) placement with paracervical block with 1% lidocaine.<br>* Other names: xylocaine, lignocaine;Device: Intrauterine device (IUD)<br>* IUD placement with or without paracervical block with 1% lidocaine.<br>|
| Active Comparator: No analgesia<br>IUD placement with no analgesia. | Other: No analgesia<br>* IUD placement without analgesia.<br>Device: Intrauterine device (IUD)<br>* IUD placement with or without paracervical block with 1% lidocaine.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Score as Assessed by a Visual Analogue Scale (VAS) | The order of overall events are: insertion of speculum, assessment of pain via a visual analogue scale (VAS) (about 30 seconds after insertion of the speculum), injection of 2cc 1% lidocaine at the tenaculum site of the cervix, placement of tenaculum (about 2-3 minutes after insertion of speculum), assessment of pain via VAS (about 30 seconds after insertion of the tenaculum), injection of 3cc 1% lidocaine at the 4 and 8 o'clock position of the cervix, insert IUD (about 4-5 minutes after insertion of tenaculum), and assessment of pain via VAS (about 30 seconds after insertion of the IUD). The Faces pain VAS was used, which ranges from 0 (very happy, no hurt) to 10 (hurts as much as you can imagine). | baseline (about 30 seconds after insertion of the speculum) | 
| Pain Score as Assessed by a Visual Analogue Scale | The order of overall events are: insertion of speculum, assessment of pain via a visual analogue scale (VAS) (about 30 seconds after insertion of the speculum), injection of 2cc 1% lidocaine at the tenaculum site of the cervix, placement of tenaculum (about 2-3 minutes after insertion of speculum), assessment of pain via VAS (about 30 seconds after insertion of the tenaculum), injection of 3cc 1% lidocaine at the 4 and 8 o'clock position of the cervix, insert IUD (about 4-5 minutes after insertion of tenaculum), and assessment of pain via VAS (about 30 seconds after insertion of the IUD). The Faces pain VAS was used, which ranges from 0 (very happy, no hurt) to 10 (hurts as much as you can imagine). | about 30 seconds after insertion of the tenaculum (tenaculum inserted about 2 to 3 minutes after insertion of speculum) | 
| Pain Score as Assessed by a Visual Analogue Scale | The order of overall events are: insertion of speculum, assessment of pain via a visual analogue scale (VAS) (about 30 seconds after insertion of the speculum), injection of 2cc 1% lidocaine at the tenaculum site of the cervix, placement of tenaculum (about 2-3 minutes after insertion of speculum), assessment of pain via VAS (about 30 seconds after insertion of the tenaculum), injection of 3cc 1% lidocaine at the 4 and 8 o'clock position of the cervix, insert IUD (about 4-5 minutes after insertion of tenaculum), and assessment of pain via VAS (about 30 seconds after insertion of the IUD). The Faces pain VAS was used, which ranges from 0 (very happy, no hurt) to 10 (hurts as much as you can imagine). | about 30 seconds after insertion of the IUD (IUD inserted about 4 to 5 minutes after insertion of tenaculum) |