NEUROCUPLE™ as an Opioid Alternative Following Total Knee Arthroplasty
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJacques E. Chelly
About this trial
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
Eligibility criteria
Qualifiers
>18 years of age
Scheduled for elective primary unilateral TKA
Disqualifiers
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
Trial design
Treatments tested in this trial
- NEUROCUPLE™ Patch
- Sham patch
- Enhanced Recovery After Surgery (ERAS) Standard of Care
Treatment groups
274 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov