12 Versus 20 mL PCB for D&E Cervical Prep

Stanford University

Status and phase: Completed; Phase 4

Conditions: Pain

Treatments: Drug: 20 mL paracervical block; Drug: 12 mL paracervical block

Study type: Interventional

Funder types: Other

Identifiers

NCT03356145

IRB-43789

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 96 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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96 participants in 2 patient groups

12 mL arm

Experimental group

Description:

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

Treatment:

Drug: 12 mL paracervical block

20 mL arm

Active Comparator group

Description:

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

Treatment:

Drug: 20 mL paracervical block