Transcutaneous Electrical Nerve Stimulation for Pain Control During First-trimester Abortion

Trial ID or NCT#

NCT05320432

Status

not recruiting iconNOT RECRUITING

Purpose

First-trimester abortion aspiration procedures are painful and sedation is typically provided. It is unsafe to drive after sedation due to the prolonged motor delay from some anesthetic agents. Without a known escort, most clinics do not allow patients to use public transportation, taxis, or rideshare services. Arranging a ride may be harder for those seeking abortion care than other surgical procedures given privacy concerns and the need to travel far distances. Additionally, some people have medical reasons that makes sedation in an outpatient abortion clinic unsafe. As abortion restrictions increase and more people need to travel far distances to access care, it is important to investigate non-pharmacologic pain control options. Transcutaneous electrical nerve stimulation (TENS) delivers a low-level electrical current through the skin. By activating the descending inhibitory systems in the central nervous system, these pulses of electrical current reduce sensitivity to pain. TENS has been shown to be effective in decreasing pain with menstrual cramps and during medication abortion, and it was found to be non-inferior to IV sedation for first-trimester procedural abortion. However, it remains unclear if TENS is better than ibuprofen and local anesthesia via paracervical block alone. The overarching goal of this research is to identify an inexpensive, non-pharmacologic, alternative pain control strategy for those with a medical or social contraindication to IV sedation. The specific aim of this project is to evaluate the efficacy of TENS to prevent pain during first-trimester procedural abortion. To achieve this objective, a blinded, randomized superiority trial comparing the use of TENS to sham for management of pain during first-trimester aspiration abortion is proposed. This research is significant because the validation of a non-pharmacologic pain management technique would decrease barriers to accessing abortion care.

Official Title

Transcutaneous Electrical Nerve Stimulation for Pain Control During First Trimester Abortion: a Blinded Randomized Controlled Trial

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 18 years old or older - English- or Spanish-fluency - <12 weeks gestation - Presenting for aspiration abortion
Exclusion Criteria:
  1. - Planned use of oral or IV sedation - Contraindications to office-based procedure as determined by attending physician - Fetal demise - Requiring pre-procedure use of misoprostol - Contraindication to TENS units use (pacemaker or epilepsy)

Investigator(s)

Kate Shaw, MD MS
Kate Shaw, MD MS
Family planning specialist, Gynecologist, Obstetrician and Gynecologist (OB-GYN)
Associate Professor of Obstetrics and Gynecology
Andrea Henkel
Andrea Henkel
Obstetrician and Gynecologist (OB-GYN), Family planning specialist
Clinical Assistant Professor, Obstetrics & Gynecology