Total Knee Arthroplasty Postoperative Pain, Opioid Reduction After TKA
Conditions
Keywords
Total Knee Arthroplasty, Postoperative Pain, TKA, Opioid Use, Non opioid Pain Management, NEUROCUPLE Patch, Knee Replacement, Acute Postoperative Pain, Randomized Clinical Trial
Brief summary
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
DEVICENEUROCUPLE™ 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
DEVICESham patch
Non-active placebo patch visually identical to NEUROCUPLE™ worn for 7 days following total knee arthroplasty.
OTHEREnhanced 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
Sponsors
Jacques E. Chelly
nCap Medical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Intervention model description
This will be a double-blinded randomized (1:1) placebo-controlled clinical trial to determine the feasibility and effectiveness of a 7-day application of the NEUROCUPLE device for pain relief and reduction of opioid refills after TKA. There is a placebo device (sham device without the captor array layer) that looks exactly like the active device, allowing for a true placebo-controlled randomized study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Consumption | From the end of surgery through 48 hours post-operative | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Scores Using Numerical Rating Scale (NRS) at Rest and during Movement | From the end of surgery through 48 hours post-operative | 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. |
| Incidence of postoperative nausea and/or vomiting (yes/no) | Postoperative Days 0-7 | Incidence and severity of postoperative nausea and vomiting will be recorded over the 7-day postoperative period as (yes/no) and compared between groups. |
| Postoperative Length of Stay | From the date of surgery until hospital discharge (within the 7-day study period) | Length of hospital stay, defined as the number of days from the date of surgery to the date of hospital discharge, will be recorded and compared between groups. Lower length of stay values indicate faster recovery, fewer complications, and earlier readiness for discharge. Higher length of stay values suggest slower recovery, increased complications, or higher postoperative symptom burden. |
Countries
United States
Contacts
CONTACTJacques E. Chelly, MD, PhD, MBA
CONTACTDayana Alsamsam, BSPS, MSc
PRINCIPAL_INVESTIGATORJacques E. Chelly, MD, PhD, MBA
University of Pittsburgh / UPMC
STUDY_DIRECTORAmy Monroe, MPH, MBA
University of Pittsburgh / UPMC
Outcome results
None listed