CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 142 enrolled
Drug / intervention
vaginal 2% Xylocaine +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02447029
NCT02447029Phase 3Completed

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

Stanford University·interventional·Posted May 18, 2015·Updated Feb 14, 2024

In Brief

A Phase 3 clinical trial evaluating vaginal 2% Xylocaine and standard lidocaine paracervical block for Pregnancy, Unwanted. Completed, enrolled 142 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMay 18, 2015
Enrollment StartApr 1, 2015
Primary CompletionJan 1, 2016
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 11.1 years ago

Interventions

vaginal 2% Xylocainedrug

patient-administered vaginal lidocaine jelly versus provider-administered standard lidocaine paracervical block

standard lidocaine paracervical blockdrug

1% lidocaine paracervical injection