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Completed

NCT Number: NCT03187002

Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Control During First Trimester Abortion

High-frequency, high-intensity transcutaneous electrical nerve-stimulation (TENS) is an inexpensive and non-invasive pain control approach. TENS, pulsating electrical currents that activate underlying nerves, does not have drug interactions or risk of overdose. Cochrane review of TENS for acute pain found inconclusive evidence. One previous abortion trial comparing TENS to IV sedation only looked at pain control in the recovery room. The investigators propose a randomized controlled trial comparing TENS to IV sedation (in conjunction with local anesthesia) among women presenting for first-trimester surgical abortion. Primary outcome will be perceived pain by Visual Analogue Scale (VAS) during aspiration.

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Key information

Conditions

Abortion in First Trimester

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Planned Parenthood Mar Monte

San Jose, California, 95126, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Presenting for surgical abortion
  • Gestational age <12 weeks
  • < 18 years of age
  • Agrees to be randomized

Exclusion criteria

  • Allergy to study medications (lidocaine, fentanyl, midazolam)
  • > 18 years of age
  • Fetal demise
  • Pre-procedure use of misoprostol
  • No means of transportation following procedure

Treatment and study plan

Transcutaneous Electrical Nerve Stimulation (TENS)

Device

Transcutaneous electrical nerve-stimulation (TENS) is a nonpharmacologic means of pain control that delivers electrical currents through the skin. These pulses of electrical current reduce pain by peripheral and central mechanisms, TENS actives descending inhibitory systems in the central nervous system to reduce sensitivity to pain (hypoalgesia). Assessment of previous TENS research identifies intensity as a critical factor in efficacy-documenting high intensity as the best means of pain control, as the higher pulse allows for deeper tissue afferents to be activated. TENS has been researched in a number of settings as pain control, including cancer pain, lower back pain, labor, and a range of gynecologic procedures and disorders.

Moderate IV Sedation

Drug

IV sedation with fentanyl and versed

SHAM: Transcutaneous electrical nerve stimulation (TENS)

Other

Sham Transcutaneous electrical nerve stimulation (TENS) to ensure blinding

SHAM: Moderate IV Sedation

Other

Sham IV to ensure blinding

Primary outcomes

  1. Aspiration Pain

    Time frame: Intraoperative, collected during procedure at the time of aspiration (up to 30 seconds)

    Pain with aspiration, assessed by visual analogue scale (VAS, 0-100mm; 0 being "no pain" and 100 being "worst pain imaginable")

Secondary outcomes

  1. Speculum Placement Pain

    Time frame: Intraoperative, collected during procedure (up to 30 seconds)

    Pain with speculum placement, assessed by visual analog scale (VAS, 0-100mm; 0 being "no pain" and 100 being "worst pain imaginable")

  2. Tenaculum Placement Pain

    Time frame: Intraoperative, collected during procedure (up to 30 seconds)

    Pain at time of tenaculum placement, assessed by visual analog scale (VAS, 0-100mm; 0 being "no pain" and 100 being "worst pain imaginable")

  3. Paracervical Block Pain

    Time frame: Intraoperative, collected during procedure (up to 30 seconds)

    Pain with paracervical block, assessed by visual analog scale (VAS, 0-100mm; 0 being "no pain" and 100 being "worst pain imaginable")

  4. Manual Cervical Dilation Pain

    Time frame: Intraoperative, collected during procedure (up to 30 seconds)

    Pain with manual cervical dilation, assessed by visual analog scale (VAS, 0-100mm; 0 being "no pain" and 100 being "worst pain imaginable")

  5. Speculum Removal Pain

    Time frame: Intraoperative, collected during procedure (up to 30 seconds)

    Pain with speculum removal, assessed by visual analog scale (VAS, 0-100mm; 0 being "no pain" and 100 being "worst pain imaginable")

  6. Total Procedure Time

    Time frame: Intraoperative, collected during procedure (up to 20 minutes)

    Time from speculum placement to speculum removal, measured in minutes

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Control During First Trimester Abortion: A Blinded Randomized Controlled Trial

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 14, 2017
Registry last updated
Nov 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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