Using electrical stimulation to manage pain after cesarean delivery
Transcutaneous Electrical Nerve Stimulation for Post-Cesarean Pain Control
This study is testing if a device that uses electrical stimulation can help women manage pain after having a cesarean delivery better than a placebo.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Hawaii Pacific Health Academic / other |
| Locations | 1 site (Honolulu, Hawaii) |
| Trial ID | NCT04399707 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of transcutaneous electrical nerve stimulation (TENS) for controlling post-operative pain in women after cesarean sections. Participants will receive either active TENS treatment or a placebo to compare pain relief outcomes. The goal is to determine if TENS can provide significant analgesia compared to no treatment. The study focuses on women undergoing scheduled or non-urgent cesarean deliveries.
Who should consider this trial
Good fit: Ideal candidates are women scheduled for a cesarean section who meet the inclusion criteria.
Not a fit: Patients with chronic pain issues, prior opioid use, or specific contraindications to TENS will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could offer a non-pharmacological method for pain management after cesarean deliveries, reducing reliance on opioids.
How similar studies have performed: Other studies have shown promise in using TENS for pain management, suggesting potential efficacy in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: \- Women undergoing scheduled or non-urgent cesarean section Exclusion Criteria: * Non-English speaking * Subjects with a history of chronic pain or chronic opioid use * Pre-operative use of opioids for more than 1 week in the preceding 6 months * Previous exposure to the TENS unit * Women with an allergy or contraindication to narcotics/NSAIDs/acetaminophen * Subjects who had a midline vertical skin incision during this operation * Subjects who did not receive intrathecal opioids at the time of their cesarean delivery * Adhesive allergies * Subjects with a pacemaker (due to the unknown effects of the TENS on the electrical activity of the heart) * Intraoperative general anesthesia * Inability to consent to the study * Postpartum tubal ligation
Where this trial is running
Honolulu, Hawaii
- Nicole Kurata — Honolulu, Hawaii, United States (Recruiting)
Study contacts
- Principal investigator: Kelly Yamasato — Physician
- Study coordinator: Nicole Kurata
- Email: nkurata@hawaii.edu
- Phone: (808)577-3344
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.