Abortion in First Trimester
Conditions
Brief 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.
Interventions
DEVICETranscutaneous 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.
DRUGModerate IV Sedation
IV sedation with fentanyl and versed
OTHERSHAM: Transcutaneous electrical nerve stimulation (TENS)
Sham Transcutaneous electrical nerve stimulation (TENS) to ensure blinding
OTHERSHAM: Moderate IV Sedation
Sham IV to ensure blinding
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Aspiration Pain | 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
| Measure | Time frame | Description |
|---|---|---|
| Total Procedure Time | Intraoperative, collected during procedure (up to 20 minutes) | Time from speculum placement to speculum removal, measured in minutes |
| Speculum Placement Pain | 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) |
| Speculum Removal Pain | 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) |
| Paracervical Block Pain | 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) |
| Manual Cervical Dilation Pain | 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) |
| Tenaculum Placement Pain | 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) |
Countries
United States
Participant flow
Recruitment details
All recruitment occurred at the Planned Parenthood site.
Participants by arm
| Arm | Count |
|---|---|
| Transcutaneous Electrical Nerve Stimulation (TENS) Transcutaneous electrical nerve stimulation (TENS)
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.
SHAM: Moderate IV Sedation: Sham IV to ensure blinding | 55 |
| Moderate IV Sedation Fentanyl, versed
Moderate IV Sedation: IV sedation with fentanyl and versed
SHAM: Transcutaneous electrical nerve stimulation (TENS): Sham Transcutaneous electrical nerve stimulation (TENS) to ensure blinding | 54 |
| Total | 109 |
Baseline characteristics
| Characteristic | Transcutaneous Electrical Nerve Stimulation (TENS) | Moderate IV Sedation | Total |
|---|---|---|---|
| Age, Continuous | 26 years STANDARD_DEVIATION 5.5 | 28 years STANDARD_DEVIATION 6 | 27 years STANDARD_DEVIATION 6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 21 Participants | 26 Participants | 47 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 32 Participants | 25 Participants | 57 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 3 Participants | 5 Participants |
| Gestational Age | 53 days | 58 days | 55 days |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 12 Participants | 10 Participants | 22 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 4 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 5 Participants | 8 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 14 Participants | 15 Participants | 29 Participants |
| Race (NIH/OMB) White | 21 Participants | 17 Participants | 38 Participants |
| Region of Enrollment United States | 55 participants | 54 participants | 109 participants |
| Sex: Female, Male Female | 55 Participants | 54 Participants | 109 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 55 | 0 / 54 |
| other Total, other adverse events | 0 / 55 | 0 / 54 |
| serious Total, serious adverse events | 0 / 55 | 0 / 54 |
Outcome results
Primary
Aspiration Pain
Pain with aspiration, assessed by visual analogue scale (VAS, 0-100mm; 0 being no pain and 100 being worst pain imaginable)
Time frame: Intraoperative, collected during procedure at the time of aspiration (up to 30 seconds)
Population: 9 participants required rescue medication (IV sedation with fentanyl and versed) during the procedure in the TENS group and were excluded from per-protocol analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Transcutaneous Electrical Nerve Stimulation (TENS) | Aspiration Pain | 73 units on a scale |
| Moderate IV Sedation | Aspiration Pain | 66 units on a scale |
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)
Time frame: Intraoperative, collected during procedure (up to 30 seconds)
Population: 9 participants required rescue medication (IV sedation with fentanyl and versed) during the procedure in the TENS group and were excluded from per-protocol analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Transcutaneous Electrical Nerve Stimulation (TENS) | Manual Cervical Dilation Pain | 67 units on a scale |
| Moderate IV Sedation | Manual Cervical Dilation Pain | 56 units on a scale |
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)
Time frame: Intraoperative, collected during procedure (up to 30 seconds)
Population: 9 participants required rescue medication (IV sedation with fentanyl and versed) during the procedure in the TENS group and were excluded from per-protocol analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Transcutaneous Electrical Nerve Stimulation (TENS) | Paracervical Block Pain | 48.5 units on a scale |
| Moderate IV Sedation | Paracervical Block Pain | 34.5 units on a scale |
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)
Time frame: Intraoperative, collected during procedure (up to 30 seconds)
Population: 9 participants required rescue medication (IV sedation with fentanyl and versed) during the procedure in the TENS group and were excluded from per-protocol analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Transcutaneous Electrical Nerve Stimulation (TENS) | Speculum Placement Pain | 27 units on a scale |
| Moderate IV Sedation | Speculum Placement Pain | 17.5 units on a scale |
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)
Time frame: Intraoperative, collected during procedure (up to 30 seconds)
Population: 9 participants required rescue medication (IV sedation with fentanyl and versed) during the procedure in the TENS group and were excluded from per-protocol analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Transcutaneous Electrical Nerve Stimulation (TENS) | Speculum Removal Pain | 38.5 units on a scale |
| Moderate IV Sedation | Speculum Removal Pain | 23 units on a scale |
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)
Time frame: Intraoperative, collected during procedure (up to 30 seconds)
Population: 9 participants required rescue medication (IV sedation with fentanyl and versed) during the procedure in the TENS group and were excluded from per-protocol analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Transcutaneous Electrical Nerve Stimulation (TENS) | Tenaculum Placement Pain | 34.5 units on a scale |
| Moderate IV Sedation | Tenaculum Placement Pain | 23.5 units on a scale |
Secondary
Total Procedure Time
Time from speculum placement to speculum removal, measured in minutes
Time frame: Intraoperative, collected during procedure (up to 20 minutes)
Population: 9 participants required rescue medication (IV sedation with fentanyl and versed) during the procedure in the TENS group and were excluded from per-protocol analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Transcutaneous Electrical Nerve Stimulation (TENS) | Total Procedure Time | 7 minutes |
| Moderate IV Sedation | Total Procedure Time | 6.4 minutes |