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NEUROCUPLE™ as an Opioid Alternative Following Total Knee Arthroplasty
Sponsor: Jacques E. Chelly
Summary
The goal of this clinical trial is to learn if the NEUROCUPLE device can reduce pain and opioid use after primary unilateral total knee arthroplasty (TKA) in adults. The main questions it aims to answer are: * Does the NEUROCUPLE device reduce postoperative pain at rest during the first 24 hours after TKA? * Does the NEUROCUPLE device reduce opioid consumption during the first 24 hours after TKA? Researchers will compare the NEUROCUPLE device to a placebo device (identical in appearance but inactive) to see if the device reduces pain and opioid use after surgery. Participants will: * Apply the NEUROCUPLE device or placebo device for 7 days following surgery * Have their pain and opioid use monitored through clinical records and patient reporting * Report pain at rest and during movement on postoperative Days 2 and 7 * Be assessed for nausea, vomiting, device-related side effects, length of hospital stay, and overall satisfaction
Official title: The Role of NEUROCUPLE™ as an Alternative to Opioids Following Total Knee Arthroplasty Patients
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
274
Start Date
2026-05
Completion Date
2027-11
Last Updated
2026-04-08
Healthy Volunteers
No
Interventions
NEUROCUPLE™ Patch
nCAP Medical has developed an effective, safe, non-opioid alternative, the NEUROCUPLE™ device, based on an innovative nanotechnology to reduce surgical pain and facilitate functional recovery while reducing opioid prescriptions, opioid-related adverse events and reducing the cost of care in millions of Americans undergoing TKA each year. The patch will be worn for 7-days
Sham patch
Non-active placebo patch visually identical to NEUROCUPLE™ worn for 7 days following total knee arthroplasty.
Enhanced Recovery After Surgery (ERAS) Standard of Care
Participants in both arms will receive approved Enhanced Recovery After Surgery (ERAS) multimodal care, including preoperative education and optimization, intraoperative minimally invasive techniques and multimodal analgesia, and postoperative early mobilization, early nutrition, pain control, and monitoring for complications
Locations (3)
UPMC East Hospital
Pittsburgh, Pennsylvania, United States
UPMC Shadyside Hospital
Pittsburgh, Pennsylvania, United States
UPMC Passavant Hospital
Pittsburgh, Pennsylvania, United States