Abortion in First Trimester, Pain
Conditions
Brief summary
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.
Detailed description
Abortion is common: one in four individuals will seek this care during their reproductive lifetime. Most abortions occur in the first trimester and nearly all - greater than 95% - occur in the outpatient clinic setting. Uterine aspiration is painful; most patients desire additional analgesia beyond local anesthesia. However, not every patient is a candidate for office sedation since multiple medical conditions are a contraindication and patients must have a ride home. The prolonged motor delay from some anesthetic agents makes driving after sedation unsafe. Without a known escort to monitor for surgical and anesthetic complications as recommended by the American Society of Anesthesia, 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. 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 an electrical current through the skin to activate the descending inhibitory systems in the central nervous system, effectively reducing sensitivity to pain. A previous trial comparing TENS to IV sedation found similar postoperative pain scores with a significantly shorter recovery time in the TENS group; however, this study did not evaluate or report intraoperative pain scores. It was found in a randomized controlled trial comparing TENS to IV sedation (in conjunction with local anesthesia) for first-trimester surgical abortion and that TENS had non-inferior pain scores to IV sedation and was considered an acceptable modality for pain control among participants. Through this proposed double blinded randomized controlled trial, it is hoped to demonstrate that TENS is a superior, non-invasive alternative pain control option for people undergoing surgical abortion in the first trimester who otherwise are not eligible for or decline IV sedation. Ultimately, the hope is to identify an inexpensive, alternative, non-pharmacologic pain control strategy for those with a medical or social contraindication to IV sedation in an effort to decrease barriers to accessing abortion care.
Interventions
A low-level electrical current through the skin activates the descending inhibitory systems in the central nervous system.
No current applied through pads.
Sponsors
Study design
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain During Cervical Dilation | Intra-operative, 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Experience | Post-operative, collected following procedure (up to 20 minutes) | Patient experience assessed by visual analog scale (VAS, 0-100mm; 0 being worst experience possible and 100 being best experience possible) |
| Procedure Time | up to 20 minutes | — |
| Pain During Procedure | Intra-operative, collected during procedure (up to 30 seconds) | Pain during aspiration assessed by visual analog scale (VAS, 0-100mm; 0 being no pain and 100 being worst pain imaginable) |
| Time Spent in Recovery | up to 1 hour | — |
| Number of Participants Who Correctly Identified Whether They Received TENS or Sham | Post-operative, collected after procedure (up to 30 seconds) | This outcome is to measure the participant's perceived group allocation. |
| Provider Perceived Ease of Procedure | Post-operative, collected after procedure (up to 30 seconds) | Provider experience assessed by visual analog scale (VAS, 0-100mm; 0 being easiest to use and 100 being most difficult to use) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Transcutaneous Electrical Nerve Stimulation (TENS) Prior to the procedure, the patient will have two sets of two self-adhesive electrodes placed parallel to the spinal cord at the T10-L1 and S2-S4 levels for TENS administration. For participants randomized to the experimental group, the non-blinded study coordinator will turn on the TENS unit 5 minutes prior to the procedure and monitor stimulating frequency level (80-100 Hz and pulse duration of 400 microseconds; intensity or frequency will be monitored to be administered to a non-painful level).
Transcutaneous electrical nerve stimulation (TENS): A low-level electrical current through the skin activates the descending inhibitory systems in the central nervous system. | 35 |
| Sham For the participants randomized to sham, the same placement of electrodes will occur, but the unit will not be delivering electrical stimulation.
Sham: No current applied through pads. | 35 |
| Total | 70 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | Transcutaneous Electrical Nerve Stimulation (TENS) | Sham | Total |
|---|---|---|---|
| Age, Continuous | 30.6 years STANDARD_DEVIATION 6.5 | 29.9 years STANDARD_DEVIATION 7.7 | 30.2 years STANDARD_DEVIATION 7.1 |
| Nulliparous | 11 Participants | 14 Participants | 25 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 9 Participants | 4 Participants | 13 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 5 Participants | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants | 3 Participants | 9 Participants |
| Race (NIH/OMB) White | 17 Participants | 20 Participants | 37 Participants |
| Region of Enrollment United States | 35 Participants | 35 Participants | 70 Participants |
| Sex: Female, Male Female | 35 Participants | 35 Participants | 70 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 / 35 | 0 / 35 |
| other Total, other adverse events | 0 / 35 | 0 / 35 |
| serious Total, serious adverse events | 0 / 35 | 0 / 35 |
Outcome results
Pain During Cervical Dilation
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: Intra-operative, collected during procedure (up to 30 seconds)
Population: Two excluded from sham as did not complete procedure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Transcutaneous Electrical Nerve Stimulation (TENS) | Pain During Cervical Dilation | 44 millimeters on VAS |
| Sham | Pain During Cervical Dilation | 50 millimeters on VAS |
Number of Participants Who Correctly Identified Whether They Received TENS or Sham
This outcome is to measure the participant's perceived group allocation.
Time frame: Post-operative, collected after procedure (up to 30 seconds)
Population: Two participants excluded from sham - did not complete procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transcutaneous Electrical Nerve Stimulation (TENS) | Number of Participants Who Correctly Identified Whether They Received TENS or Sham | 32 Participants |
| Sham | Number of Participants Who Correctly Identified Whether They Received TENS or Sham | 21 Participants |
Overall Experience
Patient experience assessed by visual analog scale (VAS, 0-100mm; 0 being worst experience possible and 100 being best experience possible)
Time frame: Post-operative, collected following procedure (up to 20 minutes)
Population: Two excluded from sham - did not complete procedure
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Transcutaneous Electrical Nerve Stimulation (TENS) | Overall Experience | 75 millimeters on VAS |
| Sham | Overall Experience | 62 millimeters on VAS |
Pain During Procedure
Pain during aspiration assessed by visual analog scale (VAS, 0-100mm; 0 being no pain and 100 being worst pain imaginable)
Time frame: Intra-operative, collected during procedure (up to 30 seconds)
Population: Two participants excluded from sham - did not complete procedure
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Transcutaneous Electrical Nerve Stimulation (TENS) | Pain During Procedure | 44 millimeters on VAS |
| Sham | Pain During Procedure | 56 millimeters on VAS |
Procedure Time
Time frame: up to 20 minutes
Population: Two excluded from sham - did not complete procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Transcutaneous Electrical Nerve Stimulation (TENS) | Procedure Time | 7.3 minutes | Standard Deviation 2.9 |
| Sham | Procedure Time | 8.4 minutes | Standard Deviation 4.1 |
Provider Perceived Ease of Procedure
Provider experience assessed by visual analog scale (VAS, 0-100mm; 0 being easiest to use and 100 being most difficult to use)
Time frame: Post-operative, collected after procedure (up to 30 seconds)
Population: Two excluded from sham - did not complete procedure
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Transcutaneous Electrical Nerve Stimulation (TENS) | Provider Perceived Ease of Procedure | 16 score on a scale |
| Sham | Provider Perceived Ease of Procedure | 15 score on a scale |
Time Spent in Recovery
Time frame: up to 1 hour
Population: Two excluded from sham - did not complete procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Transcutaneous Electrical Nerve Stimulation (TENS) | Time Spent in Recovery | 25.4 minutes | Standard Deviation 8.8 |
| Sham | Time Spent in Recovery | 24.0 minutes | Standard Deviation 10.8 |