Self-administered Lidocaine Gel for Pain-control During Cervical Preparation for Dilation and Evacuation

Study Overview
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Brief Summary
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This study seeks to compare self-administered lidocaine gel for pain control during cervical preparation for dilation and evacuation (D&E) to paracervical block.

Official Title
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Self-administered Lidocaine Gel for Pain-control During Cervical Preparation for Dilation and Evacuation: A Randomized Controlled Trial

Conditions
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Pain Management, Cervical Preparation

Intervention / Treatment
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* Drug: Lidocaine Gel (2%)
* Drug: Lidocaine Paracervical Block (1%)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women 18 and older Intrauterine pregnancy ≥16 weeks gestation English speaking competency Willing and able to sign consent forms Agree to comply with study procedures Exclusion Criteria: Women less than 18 years of age IV conscious sedation Known allergy to study medication (lidocaine) Any women not meeting inclusion criteria above will be excluded from participation

Ages Eligible for Study
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Minimum Age: 18 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Self-administered Gel<br>Patient-administered, vaginal lidocaine gel (2%)--inserted 15 minutes prior to cervical preparation procedure | Drug: Lidocaine Gel (2%)<br> <br> |
| Active Comparator: Paracervical Block<br>Provider-administered lidocaine (1%) paracervical injection--administered immediately prior to tenaculum placement | Drug: Lidocaine Paracervical Block (1%)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Perceived at the Time of Laminaria or Osmotic Dilator Insertion | Measured by visual analogue scale (VAS), 0-100; Pain was measured on a 100 mm VAS scale. Lower scores correspond to less pain, higher scores correspond to more pain. | Intraoperative; Immediately (0-30 seconds) following cervical dilation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anticipated Pain Measured by Visual Analogue Scale | Measured by visual analogue scale (VAS), 0-100, Pain was measured on a 100 mm VAS scale. Lower scores correspond to less pain, higher scores correspond to more pain. | Preoperative; 30 minutes prior to procedure | 
| Baseline Pain Measured by Visual Analogue Scale | Measured by visual analogue scale (VAS), 0-100, Pain was measured on a 100 mm VAS scale. Lower scores correspond to less pain, higher scores correspond to more pain. | Immediately prior to procedure | 
| Speculum Placement Measured by Visual Analogue Scale | Measured by visual analogue scale (VAS), 0-100; Pain was measured on a 100 mm VAS scale. Lower scores correspond to less pain, higher scores correspond to more pain. | Intraoperative; Immediately following speculum placement | 
| Overall Pain Measured by Visual Analogue Scale | Measured by visual analogue scale (VAS), 0-100; Pain was measured on a 100 mm VAS scale. Lower scores correspond to less pain, higher scores correspond to more pain. | Postoperative; Assessed once 10 minutes after procedure |