Management of Postoperative Pain After Cesarean Delivery Using Non-pharmacological Analgesic Device, NeuroCuple™
Inova Health Care Services
Summary
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.
Description
This is a single-center, sham-controlled, 3-arms, randomized, prospective study in 180 women undergoing cesarean delivery, with an expected subject enrollment duration of one year. Subjects will be screened and consented preoperatively before the scheduled case. Enrolled subjects will be randomized by research personnel using a computer generated randomization scheme in a 1:1:1 group allocation and assigned to the active device, sham device, or standard of care arms. Upon arrival to the PACU, subjects in the standard-of-care arm will receive standard postoperative pain orders at the discretio…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
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 dev…
Interventions
- DeviceNeuroCuple
Device around the abdomen over c-section bandages in the PACU
- DeviceSham
Device around the abdomen over c-section bandages in the PACU
Location
- Inova Fairfax Medical CampusFalls Church, Virginia