NeuroCuple for pain after cesarean delivery
Management of Postoperative Pain After Cesarean Delivery Using Non-pharmacological Analgesic Device, NeuroCuple™
This study will test whether the NeuroCuple non-drug wearable device can reduce pain and opioid use in women having cesarean delivery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Inova Health Care Services Academic / other |
| Locations | 1 site (Falls Church, Virginia) |
| Trial ID | NCT07185425 on ClinicalTrials.gov |
What this trial studies
This single-center, randomized (1:1:1), sham-controlled trial will enroll 180 women undergoing non-emergent cesarean delivery and randomize them to an active NeuroCuple device, a sham device, or standard postoperative care. Devices are placed in the PACU by trained staff and both patients and clinical teams are blinded to active versus sham assignment. Pain scores will be collected during the hospital stay and daily through postoperative day 4, and total opioid consumption will be measured in morphine milligram equivalents through day 4. The trial compares pain intensity and opioid use between active device, sham, and standard care groups to determine whether the device reduces postoperative pain and medication needs.
Who should consider this trial
Good fit: Adult women (18+) undergoing planned or unplanned non-emergent cesarean delivery with a Pfannenstiel incision who can consent in English or Spanish and have intact skin at the patch site are the intended participants.
Not a fit: People with active drug abuse, chronic opioid use, severe chronic pain, skin conditions preventing patch use, those requiring extended epidural care or complex additional procedures are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If effective, the device could lower postoperative pain and reduce opioid requirements after cesarean delivery.
How similar studies have performed: Similar non-pharmacologic wearable and neuromodulation approaches have shown mixed results in small trials, and direct evidence for NeuroCuple is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female 18 years or older able to provide informed consent in English or Spanish * Scheduled for a planned or unplanned non-emergent cesarean delivery under neuraxial anesthesia * Intact skin surfaces around the operative skin incision area at the site of patch application * Pfannestiel skin incision Exclusion Criteria: * Active drug abuse * Chronic opioid user * Severe chronic pain * Psoriasis vulgaris or other skin conditions precluding safe device application * Subject is concurrently participating in another research study with an investigational drug or medical device that in the Investigator's opinion could impact subject safety or study results * Subject with reasons to maintain an epidural beyond operative room * Subject with complex surgery or subject who may need more than a cesarean surgery with possible tubal sterilization procedure * Subject is deemed not suitable for the study at the discretion of the principal Investigator
Where this trial is running
Falls Church, Virginia
- Inova Fairfax Medical Campus — Falls Church, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Antonio Saad, MD — Inova Health Care Services
- Study coordinator: Antonio Saad, MD
- Email: antonio.saad@inova.org
- Phone: 7037766040
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.