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NEUROCUPLE™ Patch for Post-Surgery Pain After Knee Replacement

This study is testing a device called NEUROCUPLE™ Patch as an alternative to opioids for managing pain after total knee replacement surgery (TKA). Researchers want to see if this patch can reduce your pain and the amount of opioid medication you need in the first 24 hours after surgery. You could be eligible if you are an adult (18 years or older) scheduled for a primary, single knee replacement. The study will compare the NEUROCUPLE™ Patch to a non-active, identical-looking sham patch to determine if it helps reduce pain and opioid use.

Study design
This study plans to enroll 274 participants and will compare the NEUROCUPLE™ Patch to a sham (inactive) patch. All participants will also receive standard enhanced recovery care after surgery.
What's involved
You would wear either the NEUROCUPLE™ Patch or a sham patch for 7 days after your total knee replacement surgery. Your pain levels and opioid consumption will be measured during the first 24 hours after surgery.
Compensation
Not stated in the trial record.
Follow-up
The primary measurements for pain and opioid use are taken at 0-24 hours post-surgery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07439666

NEUROCUPLE™ as an Opioid Alternative Following Total Knee Arthroplasty

Not Yet Recruiting
NAAges 18+InterventionalTreatment
Jacques E. Chelly
~274 participants
Updated 2026-07-06 on ClinicalTrials.gov
What's tested:NEUROCUPLE™ PatchSham patchEnhanced Recovery After Surgery (ERAS) Standard of Care

At a glance

Recruiting sites
0 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Opioid Consumption
Measured over 0- 24 hours post-surgery
+1 more outcome measured

Conditions

Total Knee Arthroplasty Postoperative Pain
Opioid Reduction After TKA

Explore related trials

Total Knee Replacement

Where it's being run

3 sites across 1 states
Pennsylvania3

Study leadership

  • Jacques E. Chelly, MD, PhD, MBA · PRINCIPAL_INVESTIGATOR · University of Pittsburgh / UPMC
  • Amy Monroe, MPH, MBA · STUDY_DIRECTOR · University of Pittsburgh / UPMC

Who to contact

Jacques E. Chelly, MD, PhD, MBA
[email protected]
(412)623-6904
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • Opioid Consumption0- 24 hours post-surgery

    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.

  • Pain at Rest Using Numerical Rating Scale (NRS)0-24 hours post-surgery

    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