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

Stanford University72 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pain Management, Cervical Preparation

Interventions

Lidocaine Gel (2%)DRUG

Lidocaine Paracervical Block (1%)DRUG

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Stanford University

Palo Alto, California, United States

Outcomes

Primary Outcomes

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.

Time frame: Intraoperative; Immediately (0-30 seconds) following cervical dilation

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Postoperative; Assessed once 10 minutes after procedure

Data from ClinicalTrials.gov

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