MedTrace Logo

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

NCT02447029 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2024-02-14

Study results available
· View outcomes & findings →

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.

Conditions

  • Pregnancy, Unwanted

Interventions

DRUG

vaginal 2% Xylocaine

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

DRUG

standard lidocaine paracervical block

1% lidocaine paracervical injection

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2016-01-31
Completion
2016-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02447029 on ClinicalTrials.gov