New patch could replace opioids for knee surgery pain
NCT ID NCT06460350
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This completed trial tested a new device called the NEUROCUPLE™ patch, which uses nanotechnology to reduce pain after knee replacement surgery. 156 adults were randomly assigned to receive either the active patch or a placebo patch for 30 days. The goal was to see if the patch could lower pain and the need for opioid painkillers, offering a safer alternative.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- NEUROCUPLE™ Patch (a non-invasive device using nanotechnology)
- What this could lead to
- If effective, this patch could provide a non-opioid way to manage pain after knee replacement, reducing opioid use and side effects.
- What could go wrong
- This is a single completed trial with 156 participants. Results may not apply to all patients, and the placebo-controlled design means the active patch may not prove superior.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
156 people
The number who actually took part.
- Started
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Sep 2024
- Finished
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Jul 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * \>18 years of age * Scheduled for elective primary unilateral TKA * T-score \< 60 on the PROMIS Anxiety measure 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 * T-score ≥ 60 in any of the three PROMIS measures (i.e., sleep, anxiety, and depression) * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
UPMC Shadyside Hospital
Pittsburgh, Pennsylvania, 15232, United States
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Other studies related to the condition(s) this trial covers.
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