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

Stanford University

Status and phase: Completed; Phase 3

Conditions: Pain Management, Cervical Preparation

Treatments: Drug: Lidocaine Paracervical Block (1%); Drug: Lidocaine Gel (2%)

Study type: Interventional

Funder types: Other

Identifiers

NCT02852434

IRB-38200

Details and patient eligibility

About

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

Enrollment: 72 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: None (Open label)

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72 participants in 2 patient groups

Self-administered Gel

Experimental group

Description:

Patient-administered, vaginal lidocaine gel (2%)--inserted 15 minutes prior to cervical preparation procedure

Treatment:

Drug: Lidocaine Gel (2%)

Paracervical Block

Active Comparator group

Description:

Provider-administered lidocaine (1%) paracervical injection--administered immediately prior to tenaculum placement

Treatment:

Drug: Lidocaine Paracervical Block (1%)