Actively Recruiting
Impact of the NeuroCuple Device on Pain Management After Cesarean Delivery
Led by Inova Health Care Services · Updated on 2025-10-16
180
Participants Needed
1
Research Sites
98 weeks
Total Duration
On this page
Sponsors
I
Inova Health Care Services
Lead Sponsor
N
nCap Medical
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Impact of the NeuroCuple Device on Pain Management After Cesarean Delivery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Active drug abuse
- Chronic opioid user
- Severe chronic pain
- Psoriasis vulgaris or other skin conditions precluding safe device application
- Concurrent participation in another research study with investigational drug or device that may impact safety or results
- Need to maintain an epidural beyond the operating room
- Complex surgery or need for more than cesarean surgery with possible tubal sterilization
- Deemed not suitable for the study by the principal Investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Inova Fairfax Medical Campus
Falls Church, Virginia, United States, 22042
Actively Recruiting
Research Team
A
Antonio Saad, MD
CONTACT
M
Michelle Cassidy, phD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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