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

• Status: Completed
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Stanford University
• Treatments: Lidocaine

Criteria

Inclusion criteria:

• Women ages 18 and older undergoing elective surgical abortion at 5 and 0/7 to 11 and 6/7 weeks gestational age

• Use of IV sedation for pain management

• English or Spanish speaking

• Ability to give informed consent

Exclusion criteria:

• Any pre-operative use of misoprostol (typically given at 12 weeks and above in this clinic)

• Allergy to study medications: lidocaine, midazolam, fentanyl

• Known uterine anomaly

• Prior cervical surgery.