12 Versus 20 mL PCB for D&E Cervical Prep

Study Overview
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Brief Summary
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More research is needed to investigate methods of pain control for cervical preparation for abortion procedures. Women report pain with paracervical block injection as well as with osmotic dilator placement. This study seeks to compare a 12 mL, 2-site 1% plain lidocaine paracervical block for pain control during cervical preparation (osmotic dilator insertion) for Dilation and Evacuation (D&E) to a 20 mL 1% lidocaine 2-site paracervical block.

Detailed Description
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This is a non-inferiority, single blinded, randomized controlled trial.This study will use a 2-site, 12 mL 1% plain lidocaine injection paracervical block (PCB) technique (2 mL for tenaculum placement, 10 mL for paracervical block) will provide non-inferior pain control compared to a previously established 2-site, 20 mL 1% lidocaine injection PCB (2 mL for tenaculum placement, 18 mL for paracervical block) when administered for dilation pain control during cervical preparation.

Official Title
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12 Versus 20 mL Paracervical Block for Pain-Control During Cervical Preparation for Dilation and Evacuation: A Single-Blinded Randomized Controlled Trial

Conditions
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Pain

Intervention / Treatment
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* Drug: 12 mL paracervical block
* Drug: 20 mL paracervical block


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
Interventional Model Description: Participants will be randomized to one of two study arms via computer-generated block randomization using REDCap software.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 12 mL arm<br>Intervention: Syringe loaded with 12 mL of 1% lidocaine (120 mg); 22-gauge spinal needle 2 mL injected at the tenaculum site, either 6 or 12 o'clock superficially into the cervix The tenaculum is immediately placed at the previously injected site The remaining 10 mL are slowly injected into the cervicovaginal junction in two equal aliquots at 4 and 8 o'clock; the injection is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal) No wait time between injection and dilator insertion | Drug: 12 mL paracervical block<br>* Injection of 12 mL of lidocaine<br>|
| Active Comparator: 20 mL arm<br>Intervention: Syringe loaded with 20 mL of 1% lidocaine (120 mg); 22-gauge spinal needle 2 mL injected at the tenaculum site, either 6 or 12 o'clock superficially into the cervix The tenaculum is immediately placed at the previously injected site The remaining 18 mL are slowly injected into the cervicovaginal junction in two equal aliquots at 4 and 8 o'clock; the injection is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal) No wait time between injection and dilator insertion | Drug: 20 mL paracervical block<br>* Injection of 20 mL of lidocaine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Immediately Following Dilator Insertion | The primary objective is to determine pain perceived immediately following dilator insertion measured by Visual Analogue Scale (VAS) (0-100mm; 0 being no pain, 100 being worst pain imaginable). | Time of dilator insertion (less than 1 minute to assess pain) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anticipated Pain Immediately Prior to Dilator Insertion | Pain measured by VAS (0-100mm; 0 being no pain, 100 being worst pain imaginable). | Up to 1 minute to complete survey | 
| Patient Global Satisfaction Score | Global satisfaction (acceptability) of procedure reported by participant, measured by 0-100mm VAS; with anchors at 0 (worse than expected), 50 (what I expected), and 100 (better than expected). | Up to 1 minute to complete survey | 
| Total Procedure Time | Defined as time of speculum insertion | Up to 10 minutes | 
| Physician-reported Ease of Insertion | Measured by VAS (0-100mm; 0 being very easy, 100 being very difficult). | Up to 1 minute to complete survey | 
| Count of Participants With Procedural Complications |  | Up to 10 minutes | 
| Count of Participants With Side Effects Related to Lidocaine Administration | Side effects were not necessarily considered to be adverse events by investigator. | Up to 10 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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paracervical block, abortion, dilation and evacuation, cervical preparation