The Role of NEUROCUPLE™ as an Alternative to Opioids Following Total Knee Arthroplasty Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 274
- 试验地点
- 3
- 主要终点
- Opioid Consumption
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>18 years of age
- •Scheduled for elective primary unilateral TKA
排除标准
- •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
研究组 & 干预措施
NEUROCUPLE™ Group
This arm of subjects will receive the active NEUROCUPLE™ patch to wear for 7 days following their TKA surgery.
干预措施: NEUROCUPLE™ Patch (Device)
NEUROCUPLE™ Group
This arm of subjects will receive the active NEUROCUPLE™ patch to wear for 7 days following their TKA surgery.
干预措施: Enhanced Recovery After Surgery (ERAS) Standard of Care (Other)
Sham Group
This arm of subjects will receive the placebo (non-active, sham) patch to wear for 7 days following their TKA surgery.
干预措施: Sham patch (Device)
Sham Group
This arm of subjects will receive the placebo (non-active, sham) patch to wear for 7 days following their TKA surgery.
干预措施: Enhanced Recovery After Surgery (ERAS) Standard of Care (Other)
结局指标
主要结局
Opioid Consumption
时间窗: 0- 24 hours post-surgery
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.
Pain at Rest Using Numerical Rating Scale (NRS)
时间窗: 0-24 hours post-surgery
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
次要结局
- Pain Scores Using Numerical Rating Scale (NRS) at Rest and during Movement(Post-operative at Day 2 and Day 7)
- Patient Satisfaction(at Post-operative Day 7)
- Opioid Consumption(Post-Operative Day 0- Day 7)
- Postoperative Adverse Events and Device-Related Side Effects(Postoperative Days 0-7)
- Incidence of postoperative nausea and/or vomiting (yes/no)(Postoperative Days 0-7)
- Postoperative Length of Stay(From the date of surgery until hospital discharge (within the 7-day study period))
研究者
Jacques E. Chelly
Professor, Anesthesiology
University of Pittsburgh