drugset / Trial / NCT02447029

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

NCT02447029 ↗

Phase 3 Completed 142 enrolled Stanford University
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2015-04
Primary completion
2016-01
Completion
2016-01

Outcome

Met primary endpoint

paper Self-administration of lidocaine gel before first-trimester surgical abortion is noninferior to a traditional paracervical lidocaine block PMID 27400015 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Lidocaine Other / unclassified 1 % Other
Subject Lidocaine Other / unclassified 2 % Other

Indications

No indication recorded.