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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.
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
| Field | Value |
|---|---|
| Enrollment Target | 142 participants |
| Start Date | 2015-04 |
| Est. Completion | 2016-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗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.
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