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
This trial does not accept healthy volunteersQualifiers
>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
Design model
Parallel
Treatments tested in this trial
NEUROCUPLE™ Patch
DevicenCAP 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
Sham patch
DeviceNon-active placebo patch visually identical to NEUROCUPLE™ worn for 7 days following total knee arthroplasty.
Enhanced Recovery After Surgery (ERAS) Standard of Care
Other interventionParticipants 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
Treatment groups
274 Participants
are divided into 2 treatment groupsGroup A: NEUROCUPLE™ GroupExperimental treatment 2 interventions
Group B: Sham GroupSham comparator 2 interventions
Trial outcomes
Primary outcomes
1
Opioid Consumption
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.
Time frame
0- 24 hours post-surgery2
Pain at Rest Using Numerical Rating Scale (NRS)
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
Time frame
0-24 hours post-surgerySecondary outcomes
1
Pain Scores Using Numerical Rating Scale (NRS) at Rest and during Movement
Pain will be assessed using a Numerical Rating Scale (0 = no pain, 10 = worst pain) at rest and during movement on postoperative Days 2 and 7. Higher scores indicate worse pain.
Time frame
Post-operative at Day 2 and Day 72
Patient Satisfaction
Patient satisfaction with recovery and device use will be assessed on postoperative Day 7 using standardized questionnaires. Scores range from 0 to 10, where 0 indicates the lowest level of satisfaction and 10 indicates the highest.
Time frame
at Post-operative Day 73
Opioid Consumption
Total opioid consumption, expressed in milligrams of morphine equivalents (MME), will be recorded over the 7-day postoperative period. Opioid use will be calculated using all available data sources, including in-hospital medication administration records and the state Prescription Drug Monitoring Program (PDMP) when applicable. 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, whereas higher MME values suggest increased opioid use and potentially greater pain or slower recovery.
Time frame
Post-Operative Day 0- Day 74
Postoperative Adverse Events and Device-Related Side Effects
The incidence of postoperative adverse events, including any events determined to be related to the study device, will be recorded and compared between the treatment groups during the 7-day postoperative period. Lower incidence rates indicate fewer complications and a more favorable safety profile, whereas higher incidence rates suggest increased complications, potential device-related issues, or a less favorable safety profile.
Time frame
Postoperative Days 0-7Sponsors and contacts
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Source ClinicalTrials.gov
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