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

Phase 3

Completed

• Conditions: Pain Management, Cervical Preparation
• Interventions: Drug: Lidocaine Paracervical Block (1%); Drug: Lidocaine Gel (2%)

• Registration Number: NCT02852434
• Lead Sponsor: Stanford University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-06-20
• Study Start: 2016-07
• Study First Submitted QC: 2016-08-01
• Study First Posted: 2016-08-02
• Primary Completion: 2017-04
• Study Completion: 2017-04
• Results First Submitted: 2018-03-16
• Results First Submitted QC: 2018-03-16
• Results First Posted: 2018-04-17
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-05
• Last Update Posted: 2019-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Paracervical Block	Lidocaine Paracervical Block (1%)	Provider-administered lidocaine (1%) paracervical injection--administered immediately prior to tenaculum placement
Self-administered Gel	Lidocaine Gel (2%)	Patient-administered, vaginal lidocaine gel (2%)--inserted 15 minutes prior to cervical preparation procedure

Primary Outcome Measures

Name	Time	Method
Pain Perceived at the Time of Laminaria or Osmotic Dilator Insertion	Intraoperative; Immediately (0-30 seconds) following cervical dilation	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.

Secondary Outcome Measures

Name	Time	Method
Overall Pain Measured by Visual Analogue Scale	Postoperative; Assessed once 10 minutes after procedure	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.
Speculum Placement Measured by Visual Analogue Scale	Intraoperative; Immediately following speculum placement	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.
Anticipated Pain Measured by Visual Analogue Scale	Preoperative; 30 minutes prior to procedure	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.
Baseline Pain Measured by Visual Analogue Scale	Immediately prior to procedure	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.

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Palo Alto, California, United States