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

Self-administered Lidocaine Gel for Pain-control During Cervical Preparation for Dilation and Evacuation: A Randomized Controlled Trial

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 Overview

• Status: Completed
• Conditions: Pain Management, Cervical Preparation
• Intervention / Treatment: Drug: Lidocaine Gel (2%); Drug: Lidocaine Paracervical Block (1%)

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94305
      • Stanford University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Self-administered Gel; Patient-administered, vaginal lidocaine gel (2%)--inserted 15 minutes prior to cervical preparation procedure	Drug: Lidocaine Gel (2%)
Active Comparator: Paracervical Block; Provider-administered lidocaine (1%) paracervical injection--administered immediately prior to tenaculum placement	Drug: Lidocaine Paracervical Block (1%)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Intraoperative; Immediately (0-30 seconds) following cervical dilation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	Postoperative; Assessed once 10 minutes after procedure

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Principal Investigator, MD, MS, Stanford University

Publications and helpful links

General Publications

• Schivone GB, Lerma K, Montgomery C, Wright P, Conti JA, Blumenthal PD, Shaw KA. Self-administered lidocaine gel for local anesthesia prior to osmotic dilator placement: a randomized trial. Contraception. 2019 Mar;99(3):148-151. doi: 10.1016/j.contraception.2018.11.013. Epub 2018 Nov 27.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: June 20, 2016
• First Submitted That Met QC Criteria: August 1, 2016
• First Posted (Estimate): August 2, 2016

Study Record Updates

• Last Update Posted (Actual): June 7, 2019
• Last Update Submitted That Met QC Criteria: June 5, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Dilatation, Pathologic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: IRB-38200

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO