The Effectiveness of Tailored Patient Controlled Analgesia Based on Preoperative Pain Sensitivity in Gynecological Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 118
- 试验地点
- 2
- 主要终点
- postoperative nausea
研究概览
简要总结
Opioids via intravenous patient-controlled analgesia (IV PCA) are widely used for postoperative pain control. However, effective pain control with minimized side effects of analgesic agents is still challenging. Several studies reported that preoperative pain sensitivity measured by quantitative sensory test could predict postoperative pain. Therefore, the investigators planned this trial to evaluate the effectiveness of tailored patient-controlled analgesia based on preoperative pain sensitivity measured by pressure pain threshold in patients undergoing gynecological surgery.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients scheduled to undergo elective gynecological surgery under general anesthesia
- •patients scheduled to use IV PCA for postoperative analgesia
- •patients with American Society of Anesthesiologists (ASA) physical status classification I, II, III
排除标准
- •contraindication to fentanyl use
- •inability to communication
- •age less than 18 years, or more than 80 years
- •body weight less than 40kg, or more than 90kg
- •morbid cardiovascular disease
- •pregnancy
研究组 & 干预措施
Tailored group
Tailored regimen of IV PCA according to pain sensitivity The regimen of IV PCA will be determined according to preoperative pain sensitivity of patients. Pressure pain threshold will be measured preoperatively in these patients using pressure algometer. Patients with low pain threshold will use high dose IV PCA containing fentanyl 1500mcg, while patients with high pain threshold will use low dose IV PCA containing fentanyl 1000mcg.
干预措施: Tailored regimen of IV PCA according to pain sensitivity (Other)
control group
Regimen of IV PCA without considering pain sensitivity The regimen of IV PCA will be determined according to experimental group patient assignments. Pressure pain threshold will not be measured in these patients. Patients will use IV PCA with fentanyl 1000mcg or fentanyl 1500mcg. The determination will be paired to assignment of experimental group.
干预措施: Regimen of IV PCA without considering pain sensitivity (Other)
结局指标
主要结局
postoperative nausea
时间窗: during the postoperative 3 days
Incidence of postoperative nausea
次要结局
- incidence of postoperative vomiting(during the postoperative 3 days)
- Severity of postoperative nausea(during the postoperative 3 days)
- Incidence of other postoperative adverse effects(during the postoperative 3 days)
- Incidence of IV PCA clamping(during the postoperative 3 days)
- rescue analgesics(during the postoperative 3 days)
- antiemetic agents(during the postoperative 3 days)
- postoperative pain scores(during the postoperative 3 days)
- cumulative dose of drug that infused via IV PCA(during the postoperative 3 days)
- satisfaction score(during the postoperative 3 days)
研究者
Jin-Tae Kim
Associate professor
Seoul National University Hospital