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Completed

NCT Number: NCT03356145

12 Versus 20 mL PCB for D&E Cervical Prep

More research is needed to investigate methods of pain control for cervical preparation for abortion procedures. Women report pain with paracervical block injection as well as with osmotic dilator placement. This study seeks to compare a 12 mL, 2-site 1% plain lidocaine paracervical block for pain control during cervical preparation (osmotic dilator insertion) for Dilation and Evacuation (D&E) to a 20 mL 1% lidocaine 2-site paracervical block.

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Key information

Conditions

Pain Dilatation, Pathologic Neurologic Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Stanford University

Stanford, California, 94305, United States

About this study

This is a non-inferiority, single blinded, randomized controlled trial.This study will use a 2-site, 12 mL 1% plain lidocaine injection paracervical block (PCB) technique (2 mL for tenaculum placement, 10 mL for paracervical block) will provide non-inferior pain control compared to a previously established 2-site, 20 mL 1% lidocaine injection PCB (2 mL for tenaculum placement, 18 mL for paracervical block) when administered for dilation pain control during cervical preparation.

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

12 mL paracervical block

Drug

Injection of 12 mL of lidocaine

20 mL paracervical block

Drug

Injection of 20 mL of lidocaine

Primary outcomes

  1. Pain Immediately Following Dilator Insertion

    Time frame: Time of dilator insertion (less than 1 minute to assess pain)

    The primary objective is to determine pain perceived immediately following dilator insertion measured by Visual Analogue Scale (VAS) (0-100mm; 0 being no pain, 100 being worst pain imaginable).

Secondary outcomes

  1. Anticipated Pain Immediately Prior to Dilator Insertion

    Time frame: Up to 1 minute to complete survey

    Pain measured by VAS (0-100mm; 0 being no pain, 100 being worst pain imaginable).

  2. Patient Global Satisfaction Score

    Time frame: Up to 1 minute to complete survey

    Global satisfaction (acceptability) of procedure reported by participant, measured by 0-100mm VAS; with anchors at 0 ("worse than expected"), 50 ("what I expected"), and 100 ("better than expected").

  3. Total Procedure Time

    Time frame: Up to 10 minutes

    Defined as time of speculum insertion

  4. Physician-reported Ease of Insertion

    Time frame: Up to 1 minute to complete survey

    Measured by VAS (0-100mm; 0 being "very easy", 100 being "very difficult").

  5. Count of Participants With Procedural Complications

    Time frame: Up to 10 minutes

  6. Count of Participants With Side Effects Related to Lidocaine Administration

    Time frame: Up to 10 minutes

    Side effects were not necessarily considered to be adverse events by investigator.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

12 Versus 20 mL Paracervical Block for Pain-Control During Cervical Preparation for Dilation and Evacuation: A Single-Blinded Randomized Controlled Trial

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Nov 29, 2017
Registry last updated
Jan 23, 2024

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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