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Not yet recruiting NCT07439666

NEUROCUPLE™ as an Opioid Alternative Following Total Knee Arthroplasty

No phase Interventional Total Knee Arthroplasty Postoperative Pain Opioid Reduction After TKA

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: NEUROCUPLE™ Patch, Sham patch, Enhanced Recovery After Surgery (ERAS) Standard of Care.
Who it may be relevant to
Registry conditions: Total Knee Arthroplasty Postoperative Pain, Opioid Reduction After TKA. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

The Role of NEUROCUPLE™ as an Alternative to Opioids Following Total Knee Arthroplasty Patients

Overview

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

Interventions

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

Primary outcome measures

  • Opioid Consumption [Time frame: 0- 24 hours post-surgery]
  • Pain at Rest Using Numerical Rating Scale (NRS) [Time frame: 0-24 hours post-surgery]
Secondary outcome measures (6)
  • Pain Scores Using Numerical Rating Scale (NRS) at Rest and during Movement [Time frame: Post-operative at Day 2 and Day 7]
  • Patient Satisfaction [Time frame: at Post-operative Day 7]
  • Opioid Consumption [Time frame: Post-Operative Day 0- Day 7]
  • Postoperative Adverse Events and Device-Related Side Effects [Time frame: Postoperative Days 0-7]
  • Incidence of postoperative nausea and/or vomiting (yes/no) [Time frame: Postoperative Days 0-7]
  • Postoperative Length of Stay [Time frame: From the date of surgery until hospital discharge (within the 7-day study period)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 3 centers
  • UPMC East Hospital — Pittsburgh
  • UPMC Shadyside Hospital — Pittsburgh
  • UPMC Passavant Hospital — Pittsburgh

Identifiers

NCT: NCT07439666 · STUDY25120065

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗