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

Abortion in First Trimester Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03187002
• Other study ID #: IRB-41589
• Status: Completed
• Phase: N/A
• Start date: January 18, 2018
• Est. completion date: October 31, 2019

Study information

• Verified date: October 2020
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: October 31, 2019
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abortion in First Trimester

Intervention

Device:
• Transcutaneous electrical nerve stimulation (TENS)
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.

Drug:
• Moderate IV Sedation
IV sedation with fentanyl and versed

Other:
• SHAM: Transcutaneous electrical nerve stimulation (TENS)
Sham Transcutaneous electrical nerve stimulation (TENS) to ensure blinding
• SHAM: Moderate IV Sedation
Sham IV to ensure blinding

Locations

Country	Name	City	State
United States	Planned Parenthood Mar Monte	San Jose	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aspiration Pain	Pain with aspiration, assessed by visual analogue scale (VAS, 0-100mm; 0 being "no pain" and 100 being "worst pain imaginable")	Intraoperative, collected during procedure at the time of aspiration (up to 30 seconds)
Secondary	Speculum Placement Pain	Pain with speculum placement, assessed by visual analog scale (VAS, 0-100mm; 0 being "no pain" and 100 being "worst pain imaginable")	Intraoperative, collected during procedure (up to 30 seconds)
Secondary	Tenaculum Placement Pain	Pain at time of tenaculum placement, assessed by visual analog scale (VAS, 0-100mm; 0 being "no pain" and 100 being "worst pain imaginable")	Intraoperative, collected during procedure (up to 30 seconds)
Secondary	Paracervical Block Pain	Pain with paracervical block, assessed by visual analog scale (VAS, 0-100mm; 0 being "no pain" and 100 being "worst pain imaginable")	Intraoperative, collected during procedure (up to 30 seconds)
Secondary	Manual Cervical Dilation Pain	Pain with manual cervical dilation, assessed by visual analog scale (VAS, 0-100mm; 0 being "no pain" and 100 being "worst pain imaginable")	Intraoperative, collected during procedure (up to 30 seconds)
Secondary	Speculum Removal Pain	Pain with speculum removal, assessed by visual analog scale (VAS, 0-100mm; 0 being "no pain" and 100 being "worst pain imaginable")	Intraoperative, collected during procedure (up to 30 seconds)
Secondary	Total Procedure Time	Time from speculum placement to speculum removal, measured in minutes	Intraoperative, collected during procedure (up to 20 minutes)