Total Knee Arthroplasty Postoperative PainNCT07439666
NEUROCUPLE™ as an Opioid Alternative Following Total Knee Arthroplasty
A study testing NEUROCUPLE™ Patch in people with Total Knee Arthroplasty Postoperative Pain and Opioid Reduction After TKA, run by Jacques E. Chelly at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Knee Arthroplasty Postoperative Pain, Opioid Reduction After TKA
- What is being tested?
- NEUROCUPLE™ Patch
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 274 participants
- Where
- 3 sitesUnited States
- Study dates
- Dec 2026to Nov 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >18 years of age
- Scheduled for elective primary unilateral TKA
Who cannot join
- 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
Show all 9Show fewer
- Patients undergoing knee replacement revision
- Patients with limited mobility (in a wheelchair or requiring a walker)
- Patients who are not returning home after surgery
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites
UPMC East Hospital
Pittsburgh, Pennsylvania, 15146
Jacques E. Chelly, MD, PhD, MBA
UPMC Shadyside Hospital
Pittsburgh, Pennsylvania, 15232
Amy Monroe, MPH, MBA, 412-623-6382, monroeal@upmc.edu
Dayana Alsamsam, BSPS, MSc, alsamsamd@upmc.edu
UPMC Passavant Hospital
Pittsburgh, Pennsylvania, 15237
Jacques E. Chelly, MD, PhD, MBA
About this study
Official title: The Role of NEUROCUPLE™ as an Alternative to Opioids Following Total Knee Arthroplasty Patients
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:
Read more
- 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
- Being tested
- NEUROCUPLE™ Patch, Sham patch, Enhanced Recovery After Surgery (ERAS) Standard of Care
- Keywords
- Total Knee Arthroplasty, Postoperative Pain, TKA, Opioid Use, Non opioid Pain Management, NEUROCUPLE Patch, Knee Replacement, Acute Postoperative Pain, Randomized Clinical Trial
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NEUROCUPLE™ PatchDevice
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 patchDevice
Non-active placebo patch visually identical to NEUROCUPLE™ worn for 7 days following total knee arthroplasty.
Enhanced Recovery After Surgery (ERAS) Standard of CareOther
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
| Study group | Role | What they receive |
|---|---|---|
| NEUROCUPLE™ Group | Experimental | This arm of subjects will receive the active NEUROCUPLE™ patch to wear for 7 days following their TKA surgery. Receives: 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. Receives: Device: Sham patch; Other: Enhanced Recovery After Surgery (ERAS) Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 0-24 hours post-surgery
Secondary outcomes (6)
Pain Scores Using Numerical Rating Scale (NRS) at Rest and during Movement
Pain will be assessed using a Numerical Rating Scale (0 = no pain, 10 = worst pain) at rest and during movement on postoperative Days 2 and 7. Higher scores indicate worse pain.
Measured: Post-operative at Day 2 and Day 7
Patient Satisfaction
Patient satisfaction with recovery and device use will be assessed on postoperative Day 7 using standardized questionnaires. Scores range from 0 to 10, where 0 indicates the lowest level of satisfaction and 10 indicates the highest.
Measured: at Post-operative Day 7
Opioid Consumption
Total opioid consumption, expressed in milligrams of morphine equivalents (MME), will be recorded over the 7-day postoperative period.
Opioid use will be calculated using all available data sources, including in-hospital medication administration records and the state Prescription Drug Monitoring Program (PDMP) when applicable.
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, whereas higher MME values suggest increased opioid use and potentially greater pain or slower recovery.
Measured: Post-Operative Day 0- Day 7
Postoperative Adverse Events and Device-Related Side Effects
The incidence of postoperative adverse events, including any events determined to be related to the study device, will be recorded and compared between the treatment groups during the 7-day postoperative period.
Lower incidence rates indicate fewer complications and a more favorable safety profile, whereas higher incidence rates suggest increased complications, potential device-related issues, or a less favorable safety profile.
Measured: Postoperative Days 0-7
Incidence of postoperative nausea and/or vomiting (yes/no)
Incidence and severity of postoperative nausea and vomiting will be recorded over the 7-day postoperative period as (yes/no) and compared between groups.
Measured: Postoperative Days 0-7
Postoperative Length of Stay
Length of hospital stay, defined as the number of days from the date of surgery to the date of hospital discharge, will be recorded and compared between groups.
Lower length of stay values indicate faster recovery, fewer complications, and earlier readiness for discharge. Higher length of stay values suggest slower recovery, increased complications, or higher postoperative symptom burden.
Measured: From the date of surgery until hospital discharge (within the 7-day study period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study startDec 2026 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee Arthroplasty Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 274 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jacques E. Chelly
- Sponsor type
- University, hospital or other
- Collaborators
- nCap Medical
- Responsible party
- Sponsor-investigator, Jacques E. Chelly, University of Pittsburgh
- Investigators
- Jacques E. Chelly, MD, PhD, MBA, Principal investigator, University of Pittsburgh / UPMCAmy Monroe, MPH, MBA, Study director, University of Pittsburgh / UPMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07439666
- Sponsor's protocol ID
- STUDY25120065
- Status last verified
- Jul 2026
- First submitted
- 23 Feb 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No