The Role of Intraoperative Opioids in the Transition From Acute to Chronic Opioid Use and Chronic Pain
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 入组人数
- 700
- 试验地点
- 1
- 主要终点
- PACU Opioid Medication Administered
研究概览
简要总结
In the current opioid crisis, the use of opioids as the main pain management method is recognized as a consistent risk factor for chronic opioid use and the development of Opioid Use Disorder (OUD), as well as related complications like overdose fatalities among surgical patients. The most recent data suggests that 3.1%-10.5% of surgical patients are at risk of developing OUD. On average, there are over 40 million major surgeries that require post-op pain management, taking place in the United States each year. This puts over 1 million American surgical patients at risk for opioid dependency and misuse.
This is a prospective randomized controlled intervention study that will examine the physical and emotional outcomes of surgical patients who receive intraoperative Opioid-Free Anesthesia (OFA) supplemented with Non-Opioid Analgesia (NOAs), and how this relates to surgical patients who receive intraoperative Opioid-Based Anesthesia (OBA).
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
- None
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 old
- •scheduled for an elective, unilateral Total Knee Arthroplasty (TKA)
- •anticipated to stay in PACU after surgery
- •receiving general anesthesia (i.e. fentanyl, etc.)
- •receiving spinal regional anesthesia
排除标准
- •<18 years of age
- •sent to the ICU at any point during their hospital stay
- •scheduled for a bilateral TKA
- •received intraoperative opioids other than fentanyl
- •received patient-controlled analgesia in PACU
研究组 & 干预措施
Opioid-based anesthesia (OBA) Group
Subjects enrolled in this arm will receive IV-acetaminophen, IV-lidocaine, and fentanyl prior to intubation.
干预措施: Opioid-based anesthesia (Drug)
Opioid-free anesthesia (OFA) Group
Subjects enrolled in this arm will receive IV-acetaminophen, IV-lidocaine, dexmedetomidine, and ketamine prior to intubation.
干预措施: Opioid-free anesthesia (Drug)
结局指标
主要结局
PACU Opioid Medication Administered
时间窗: Postoperative Day 5
Medications will be extracted from the electronic medical records. Opioid-based medications will be reported as mean(SD).
PACU Non-Opioid Medication Administered
时间窗: Postoperative Day 5
Medications will be extracted from the electronic medical records.Non-opioid-based medications will be reported as mean(SD).
PACU NRS Pain Score at Rest
时间窗: Postoperative Day 5
Numerical Rating Scale (NRS) Pain Scores will be self reported on a scale of 0-10, 0 being no pain at all, 10 being worst pain imaginable. Pain scores at rest will be averaged and reported as mean(SD).
PACU NRS Pain Score with Movement
时间窗: Postoperative Day 5
Numerical Rating Scale (NRS) Pain Scores will be self reported on a scale of 0-10, 0 being no pain at all, 10 being worst pain imaginable. Pain scores with movement will be averaged and reported as mean(SD).
次要结局
未报告次要终点
研究者
Jacques E. Chelly
Professor
University of Pittsburgh