NEUROCUPLE™ as an Opioid Alternative Following Total Knee Arthroplasty

NCT07439666 | Not Yet Recruiting FDA Device

• 1 other identifier: STUDY25120065
• Study Type: interventional
• Target: 274
• Locations: 1 country
• Sites: 3

Brief 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

Conditions

Total Knee Arthroplasty Postoperative Pain; Opioid Reduction After TKA

Keywords

Total Knee Arthroplasty; Postoperative Pain; TKA; Opioid Use; Non opioid Pain Management; NEUROCUPLE Patch; Knee Replacement; Acute Postoperative Pain; Randomized Clinical Trial

Outcome Measures

Primary Outcomes (2)

• Opioid Consumption

  Total opioid consumption, expressed in milligrams of morphine equivalents (MME), during the first 24 hours following surgery. Opioid use will be calculated using all available data sources, including in-hospital medication administration records and, when applicable, the state Prescription Drug Monitoring Program (PDMP). MME values will be compared between the NEUROCUPLE™ patch group and the placebo patch group. Lower MME values indicate reduced opioid requirements and may reflect improved postoperative pain control, while higher MME values suggest increased opioid use and potentially greater pain or slower recovery.

  0- 24 hours post-surgery

• Pain at Rest Using Numerical Rating Scale (NRS)

  Pain at rest during the first 24 hours after surgery will be assessed using a Numerical Rating Scale (NRS; 0 = no pain, 10 = worst pain) and compared between the NEUROCUPLE™ patch group and the placebo patch group. Higher scores indicate worse pain

  0-24 hours post-surgery

Secondary Outcomes (6)

• Pain Scores Using Numerical Rating Scale (NRS) at Rest and during Movement

  Post-operative at Day 2 and Day 7

• Patient Satisfaction

  at Post-operative Day 7

• Opioid Consumption

  Post-Operative Day 0- Day 7

• Postoperative Adverse Events and Device-Related Side Effects

  Postoperative Days 0-7

• Incidence of postoperative nausea and/or vomiting (yes/no)

  Postoperative Days 0-7

Study Arms (2)

NEUROCUPLE™ Group

EXPERIMENTAL

This arm of subjects will receive the active NEUROCUPLE™ patch to wear for 7 days following their TKA surgery.

Device: NEUROCUPLE™ Patch; Other: Enhanced Recovery After Surgery (ERAS) Standard of Care

Sham Group

SHAM COMPARATOR

This arm of subjects will receive the placebo (non-active, sham) patch to wear for 7 days following their TKA surgery.

Device: Sham patch; Other: Enhanced Recovery After Surgery (ERAS) Standard of Care

Interventions

Enhanced Recovery After Surgery (ERAS) Standard of Care OTHER

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

NEUROCUPLE™ Group; Sham Group

NEUROCUPLE™ Patch DEVICE

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

NEUROCUPLE™ Group

Sham patch DEVICE

Non-active placebo patch visually identical to NEUROCUPLE™ worn for 7 days following total knee arthroplasty.

Sham Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>18 years of age
• Scheduled for elective primary unilateral TKA

You may not qualify if:

• Children (\<18 yr.)
• Pregnant women
• Active alcoholism (defined as daily use of more than 1 liter of wine and /or 3 or more shots of hard liquor) or drug abuse (defined as daily use of illicit drugs)
• Severe chronic pain condition that requires daily preoperative opioid dependence
• Other concomitant surgery being performed in addition to TKA
• Patients undergoing bilateral TKA
• Patients undergoing knee replacement revision
• Patients with limited mobility (in a wheelchair or requiring a walker)
• Patients who are not returning home after surgery

Sponsors & Collaborators

• Jacques E. Chelly: lead
• nCap Medical: collaborator

Study Sites (3)

UPMC East Hospital

Pittsburgh, Pennsylvania, 15146, United States

Location

UPMC Shadyside Hospital

Pittsburgh, Pennsylvania, 15232, United States

Location

UPMC Passavant Hospital

Pittsburgh, Pennsylvania, 15237, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Enhanced Recovery After Surgery; Standard of Care

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Perioperative Care; Surgical Procedures, Operative; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Jacques E. Chelly, MD, PhD, MBA

  University of Pittsburgh / UPMC

  PRINCIPAL INVESTIGATOR

• Amy Monroe, MPH, MBA

  University of Pittsburgh / UPMC

  STUDY DIRECTOR

Central Study Contacts

Jacques E. Chelly, MD, PhD, MBA

CONTACT

(412)623-6904; ChelJE@anes.upmc.edu

Dayana Alsamsam, BSPS, MSc

CONTACT

412-123-4567; alsamsamd@upmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Anesthesiology

Model Details: This will be a double-blinded randomized (1:1) placebo-controlled clinical trial to determine the feasibility and effectiveness of a 7-day application of the NEUROCUPLE device for pain relief and reduction of opioid refills after TKA. There is a placebo device (sham device without the captor array layer) that looks exactly like the active device, allowing for a true placebo-controlled randomized study.

Study Record Dates

• First Submitted: February 23, 2026
• First Posted: February 27, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2027
• Last Updated: April 8, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)