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

Study Overview
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Brief Summary
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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.

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

Conditions
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Abortion in First Trimester

Intervention / Treatment
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* Device: Transcutaneous electrical nerve stimulation (TENS)
* Drug: Moderate IV Sedation
* Other: SHAM: Transcutaneous electrical nerve stimulation (TENS)
* Other: SHAM: Moderate IV Sedation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transcutaneous electrical nerve stimulation (TENS)<br>Transcutaneous electrical nerve stimulation (TENS) | Device: Transcutaneous electrical nerve stimulation (TENS)<br>* 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.<br>Other: SHAM: Moderate IV Sedation<br>* Sham IV to ensure blinding<br>|
| Active Comparator: Moderate IV Sedation<br>Fentanyl, versed | Drug: Moderate IV Sedation<br>* IV sedation with fentanyl and versed<br>Other: SHAM: Transcutaneous electrical nerve stimulation (TENS)<br>* Sham Transcutaneous electrical nerve stimulation (TENS) to ensure blinding<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| Total Procedure Time | Time from speculum placement to speculum removal, measured in minutes | Intraoperative, collected during procedure (up to 20 minutes) |