About this trial
This will be a single-center, sham-controlled, 3 arms, randomized (1:1:1) prospective study in females undergoing cesarean delivery to investigate the impact of NeuroCuple™ non-pharmacological analgesic device for management of postoperative pain. The investigators hypothesize that women treated with the Neurocuple device will experience less pain and consequently require less opioid pain medication after cesarean delivery compared to women who receive standard post-surgical medication.
Eligibility criteria
Qualifiers
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
Disqualifiers
Active drug abuse
Chronic opioid user
Severe chronic pain
Psoriasis vulgaris or other skin conditions precluding safe device application
Trial design
Treatments tested in this trial
- NeuroCuple
- Sham
Treatment groups
Sponsors and collaborators
Inova Health Care Services
Lead sponsor
nCap Medical
Collaborator