Sufentanil Sublingual Tablet System For Management Of Postoperative Pain In Enhanced Recovery After Surgery Pathway For Total Knee Arthroplasty: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Postoperative pain score assessed at 24 hours
研究概览
简要总结
The aim of this study is to assess the effectiveness of Sublingual Sufentanil Tablets System (SSTS, Zalviso ®) to control postoperative pain after total knee arthroplasty in the context of early rehabilitation program.
SSTS is a novel patient controlled analgesia system wich does not require intravenous access, potentially improving pain control and promoting mobilization.
SSTS will be randomly compared to nurse-driven oral Oxycodone.
详细描述
Even with multimodal analgesia (combining local anesthetic infiltration, corticosteroids, non-steroidal anti-inflammatory drugs and acetaminophen), total knee arthroplasty is associated with acute moderate-to-severe postoperative pain requiring opioids treatment. We compare the efficacy of SSTS and oral Oxycodone in this context.
After written informed consent, patients will be randomly assigned postoperatively to SSTS or Oral oxycodone group at a ratio 1:1. Pain scores, mobilization and patient satisfaction will be analyzed.
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
- •Adult patients (age ≥ 18 years)
- •Scheduled for unilateral total knee arthroplasty under spinal anesthesia
- •American Society of Anesthesiologists (ASA) class 1-3
排除标准
- •Contraindication to medication used in our multimodal analgesia protocol (solumedrol, celecoxib, acetaminophen, ropivacaine)
- •Allergy to study medications
- •History of addiction or preoperative chronic use of opioids
- •Unicompartmental or revision knee replacement
研究组 & 干预措施
SSTS group
Patients received sufentanil nanotab patient controlled analgesia (PCA) system (Zalviso) 15 mcg with 20 min of lockout interval during 48 hours postoperatively
干预措施: Sufentanil Sublingual Tablet (Drug)
Oxycodone group
Patients received oxycodone extended-release tablet (OxyContin) 10 mg every 12 hours systematically plus Oxycodone 5 mg every 6 hours if numeric rating scale is above 3 during the 48 hours postoperatively
干预措施: Oxycodone oral tablet and oxycodone extended-release oral tablet (Drug)
结局指标
主要结局
Postoperative pain score assessed at 24 hours
时间窗: 24 hours after surgery
A numerical pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 \[100-mm scale\]) will be used to evaluate pain at rest and dynamically 24 hours after surgery
次要结局
- Postoperative pain scores assessed over 48 hours(2 hours, 6 hours, 12 hours, 18 hours, 24 hours, 30 hours, 36 hours, 42 hours, 48 hours after surgery)
- Time to first mobilization(2 hours, 6 hours, 12 hours, 18 hours, 24 hours, 30 hours, 36 hours, 42 hours, 48 hours after surgery)
- Patient satisfaction(At completion of the study period of 48 hours)