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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2017-04-30

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.

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Detailed Description

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Conditions

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Pain Management, Cervical Preparation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Self-administered Gel

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

Group Type EXPERIMENTAL

Lidocaine Gel (2%)

Intervention Type DRUG

Paracervical Block

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

Group Type ACTIVE_COMPARATOR

Lidocaine Paracervical Block (1%)

Intervention Type DRUG

Interventions

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Lidocaine Gel (2%)

Intervention Type DRUG

Lidocaine Paracervical Block (1%)

Intervention Type DRUG

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