NEUROCUPLE™ as an Opioid Alternative Following Total Knee Arthroplasty

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:

• 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

Inclusion Criteria:

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

Exclusion Criteria:

• 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