Prospective Randomized Controlled Study of Individualized PCA Model Based on Multi-dimensional Strategies (Cumulative Opioid Consumption Between Variable-Rate Feedback Infusion and Fixed-Rate Basal Infusion Modes)
概览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Beijing Tiantan Hospital
- 入组人数
- 426
- 试验地点
- 1
- 主要终点
- Cumulative opioid consumption
概览
简要总结
Perioperative pain management affects patient recovery. However, the rate of moderate to severe postoperative pain is as high as 73.8%, which hinders recovery and increases the risk of complications. Although opioids are the first-line analgesics, excessive use leads to adverse reactions. The traditional fixed-rate PCA mode is difficult to match the changes in postoperative pain. This study will compare different PCA mode optimization strategies, assuming that they can reduce opioid dosage, improve analgesic effect, and reduce adverse reactions, providing high-quality evidence-based basis for postoperative analgesia and promoting individualized and intelligent management.
详细描述
Perioperative pain management significantly impacts patient recovery outcomes. However, the incidence of moderate to severe postoperative pain remains high at 73.8%, which impedes recovery and increases complication risks. Although opioids serve as first-line analgesics, excessive use causes numerous adverse reactions. The traditional fixed-rate Patient-Controlled Analgesia (PCA) mode fails to adapt to dynamic postoperative pain variations. This study will compare different PCA optimization strategies, hypothesizing that these approaches can reduce opioid dosage, enhance analgesic effectiveness, and minimize adverse reactions. The research aims to provide evidence-based foundations for postoperative analgesia, promoting individualized and intelligent pain management systems that better serve patient needs throughout recovery.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged between 18 to 65 years;
- •American Society of Anesthesiologists physical status Ⅰ - Ⅲ;
- •Patients scheduled for elective mixed surgery were enrolled. Mixed surgeries included thoracoscopic surgery, laparoscopic surgery, hysteroscopy surgery, laparotomy, thoracotomy, open spinal surgery, craniotomy, and so on.
排除标准
- •Allergy to PCA medications;
- •Presence of chronic pain syndromes;
- •Presence of psychiatric disorders, or severe cardiovascular, cerebrovascular, renal, or hepatic dysfunction.
研究组 & 干预措施
Fixed-rate basal infusion mode group
干预措施: Fixed-rate basal infusion mode (Procedure)
Variable-rate feedback infusion mode group
干预措施: Variable-rate feedback infusion mode (Procedure)
结局指标
主要结局
Cumulative opioid consumption
时间窗: Within the first 24 hours postoperatively
次要结局
- Resting and movement pain score was assessed by NRS(At 1, 6, 12, 24, and 48 hours postoperatively)
- Cumulative PCA volume consumption(Within the first 24 hours postoperatively)
- Frequency of additional rescue analgesics(At 12, 24, and 48 hours postoperatively)
- Dosage of additional rescue analgesics(At 12, 24, and 48 hours postoperatively)
- Postoperative quality of recovery(At 24, and 48 hours postoperatively)
- Quality of sleep(At 24, and 48 hours postoperatively)
- The level of sedation and agitation(At 12, and 24 hours postoperatively)
- The degree of nausea and vomiting(At 12, 24, and 48 hours postoperatively)
- The patient's satisfaction with PCA(At 24 hours postoperatively)
研究者
Fang Luo
Director, Department of Pain Management, Principal Investigator, Clinical Professor
Beijing Tiantan Hospital