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
This trial does not accept healthy volunteersQualifiers
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
Parallel
Treatments tested in this trial
NeuroCuple
DeviceDevice around the abdomen over c-section bandages in the PACU
Sham
DeviceDevice around the abdomen over c-section bandages in the PACU
Treatment groups
Trial outcomes
Primary outcomes
Total Milligram Morphine Equivalents (MME)
Total opioid intake in MME on postoperative days 4 or before discharge.
Secondary outcomes
Pain reduction
Reduction (percentage decrease) in pain score (0-10 numeric rating scale) from day of surgery through postoperative day 4.
Quality of Recovery
Quality of recovery assessment evaluated on postoperative days 1-4 (Swedish Web Version of Quality of Recovery (SwQoR))
Opioid-related adverse events
Overall incidence of opioid-related adverse effects including maternal PONV, sedation, constipation in POD 0-4
Sponsors and contacts
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Inova Health Care Services
Lead sponsor
nCap Medical
Collaborator