Opioid-Sparing Protocol Using for Postoperative Pain Management Comparing With Opioid-based Patient Control Analgesia After Simultaneous Bilateral Total Knee Arthroplasty: a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Pain scores using numerical rating scale (VAS, 0 to 10) at motion
研究概览
简要总结
The concern for the opioid use in the total knee arthroplasty continues to rise in recent decades. Historically, the total knee arthroplasty consumed high doses opioids in the postoperative periods. Compared to the Opioid-Based patient controlled analgesia(PCA), the opioid-sparing protocol may have benefits to decrease the concerns of the opioid use and opioid-related complication and provides the equivalent efficacy for pain control. The purpose of this trial in to provide a novel opioid-sparing protocol (OSP) to evaluate the efficacy for pain control and reducing the immediate postoperative opioid consumption.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patient with bilateral advanced knee osteoarthritis undergoing simultaneous bilateral total knee arthroplasty surgery
- •willing to participate in this study and randomly allocated to either opioid-sparing protocol or PCA protocol.
排除标准
- •patient who refused to participate or with contraindication or hypersensitivity to any of the study drugs
- •chronic pain disorder (exceeding 50 mg oral morphine equivalence per day at time of recruitment)
- •substance abuse (e.g. alcoholism)
- •severe renal impairment.
研究组 & 干预措施
Opioid Sparing Protocol
Preemptive(before incision): Parecoxib sodium 40 mg Postoperative: Parecoxib sodium 40 mg was given intravenously every 12 hours for 4 more doses.
干预措施: Opioid-Sparing Protocol (Drug)
Opioid Based Patient Controlled Analgesia
Preemptive(before incision) and Postoperative: the initial setting was 0.01mg/kg*hour, patient-controlled dose 2 mg, lock-out 5 minutes and limited 40mg in each 4 hours; adjusted by the PCA staff
干预措施: Opioid-Based Patient Controlled Analgesia (Drug)
结局指标
主要结局
Pain scores using numerical rating scale (VAS, 0 to 10) at motion
时间窗: Post-operative 72 hour hours after surgery
Post-operative 72 hours
Pain scores using numerical rating scale (VAS, 0 to 10) at rest
时间窗: Post-operative 72 hours after surgery
Post-operative 72 hours
次要结局
- maximum angle of continuous passive motion (CPM) as tolerated (Degrees)(0-72 hours after surgery)
- Satisfaction scale (0-100 points)(postoperative 2 weeks after surgery)
- Cumulative morphine consumption(mg)(0-72 hours after surgery)
- Length of hospital stay (LOS) (Days)(After surgery until discharge (about 3-5 days after surgery))
- drug-related (opioid) adverse events(0-72 hours after surgery)