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Completed

NCT Number: NCT02852434

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

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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Key information

Conditions

Pain Management, Cervical Preparation Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Stanford University

Palo Alto, California, 94305, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lidocaine Gel (2%)

Drug

Lidocaine Paracervical Block (1%)

Drug

Primary outcomes

  1. Pain Perceived at the Time of Laminaria or Osmotic Dilator Insertion

    Time frame: 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 outcomes

  1. Anticipated Pain Measured by Visual Analogue Scale

    Time frame: 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.

  2. Baseline Pain Measured by Visual Analogue Scale

    Time frame: 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.

  3. Speculum Placement Measured by Visual Analogue Scale

    Time frame: 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.

  4. Overall Pain Measured by Visual Analogue Scale

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 2, 2016
Registry last updated
Jun 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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