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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, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (82% lower). 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.
Primary Outcome
This is the amount of pain self-reported by the patient at the time of cervical dilation. VAS ranged from 0 to 100 mm, 0 equals no pain, 100 equals worse pain imaginable.
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 |
What the finished NCT02447029 record still lists
NCT02447029 is an interventional study that assigns participants to a tested intervention. The registered 142 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 2 interventions - of which vaginal 2% Xylocaine is the first listed.
NCT02447029 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02447029's enrollment target sits among peer trials
142 1559th of 2000 higher than 438 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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