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Transcutaneous Electrical Nerve Stimulation for Pain Control During First-trimester Abortion
Recruiting
Trial ID: NCT05320432
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
Stanford Investigator(s)
Kate Shaw, MD MS
Associate Professor of Obstetrics and Gynecology
Andrea Henkel
Clinical Assistant Professor, Obstetrics & Gynecology
Eligibility
Inclusion Criteria:
- 18 years old or older
- English- or Spanish-fluency
- <12 weeks gestation
- Presenting for aspiration abortion
Exclusion Criteria:
- 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)
Intervention(s):
device: Transcutaneous electrical nerve stimulation (TENS)
device: Sham
Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305