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NCT02447029 · ClinicalTrials.gov registry record · Phase 3

Self-Administered Lidocaine Gel for Pain Management With First Trimester Surgical Abortion: A Randomized Controlled Trial

A Phase 3 study, sponsored by Stanford University.

Completed
Registry status
Phase 3
Development phase
142
Enrollment target

NCT02447029: Completed Phase 3 study, sponsored by Stanford University.

NCT02447029 is a Phase 3 study that has completed, run by Stanford University. The registered enrollment target is 142 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02447029, a Phase 3 study, has completed, sponsored by Stanford University.

COMPLETED
Registry status
Phase 3
Development phase
142 participants
Enrollment target

Study Summary

Despite global efforts to decrease discomfort during surgical abortion, pain remains a limiting factor in where and how procedures are performed. Several studies have investigated different methods of delivering cervical anesthesia prior to abortion, however to the best of the investigators' knowledge, there is no published data that 1) rigorously examines the effect of a time interval between local anesthetic administration and procedure initiation, or 2) explores whether adequate pain relief is possible through self-administered, non-invasive means alone. Research in this area has a significant public health impact, given the large number of women worldwide who seek abortions. The investigators propose to explore the effect of a locally applied vaginal lidocaine gel in place of the traditional paracervical block prior to first trimester surgical abortion. They hypothesize that lidocaine gel is no worse than paracervical block at decreasing abortion related pain at a variety of time points throughout the procedure. This is a non-inferiority, open label, randomized controlled trial. If self-administered vaginal gel is acceptable and effective, it would increase options for pain control during abortion and other gynecologic procedures.

Interventions

  • DRUG vaginal 2% Xylocaine
  • DRUG standard lidocaine paracervical block

Trial Details

FieldValue
Enrollment Target 142 participants
Start Date 2015-04
Est. Completion 2016-01
Phase Phase 3

Sponsor

Stanford University

1,744 total trials

What the Registry Record Tells You About NCT02447029

The ClinicalTrials.gov registry entry for NCT02447029 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 142 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Stanford University, which has 1,744 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which vaginal 2% Xylocaine is the first listed.

NCT02447029 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02447029 about?

NCT02447029 is a clinical study titled "Self-Administered Lidocaine Gel for Pain Management With First Trimester Surgical Abortion: A Randomized Controlled Trial". Despite global efforts to decrease discomfort during surgical abortion, pain remains a limiting factor in where and how procedures are performed. Several studies have investigated different methods of delivering cervical anesthesia prior to abortion, however to the best of the investigators' knowled...

What is the current status of trial NCT02447029?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 142 participants. The study started on 2015-04. Estimated completion is 2016-01.

What interventions are being tested in trial NCT02447029?

The interventions under investigation include: vaginal 2% Xylocaine (DRUG), standard lidocaine paracervical block (DRUG).

Who is sponsoring clinical trial NCT02447029?

This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.