Comparison of Analgesic Effects According to Patient-controlled Epidural Analgesia Modes in Patients Undergoing Open Gastrectomy: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Postoperative pain (numerical rating scale: 0 ~ 10)
研究概览
简要总结
Epidural PCA (patient controlled analgesia) for post-operative pain management are effective analgesic method. It is widely used in the postoperative pain management for decades.
PCA pumps typically set a fixed basal infusion rate to infuse the analgesics at a constant rate per every hour (conventional mode). In contrast, the newly developed computer-integrated patient-controlled analgesia (CIPCA) mode increases or decreases the basal infusion rate with the use of the patient's bolus button. The CIPCA mode sets the basal infusion rate, the increase / decrease rate of basal rate, and the increment / decrement interval. If the patient presses the bolus button within the set time interval, the set infusion rate is increased because the analgesic is more required. If the bolus button is not pressed during the set time interval, the infusion rate is decreased. Therefore, it can be said that it is an effective method to control the dose of analgesic agent more sensitively to changes in patient's needs and pain.
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •elective open gastrectomy due to stomach cancer
- •ASA classification Ⅰ-Ⅲ
排除标准
- •hematologic clotting defect
- •distance metastasis
- •PCA drug (fentanyl, Ropivacaine) allergy
- •Patients who can not read the consent form or are not fluent in Korean (illiterate, foreigner)
- •pregnant, lactating women
研究组 & 干预措施
CIPKA mode
The newly developed computer-integrated patient-controlled analgesia (CIPCA) mode increases or decreases the basal infusion rate with the use of the patient's bolus button.
干预措施: Apply CIPKA mode (Device)
Conventional mode
The conventional mode in which only the basal infusion rate is set to be fixed.
干预措施: Conventional mode (Device)
结局指标
主要结局
Postoperative pain (numerical rating scale: 0 ~ 10)
时间窗: at 6 hours postoperatively
次要结局
- PCA total dose/additional analgesic dose(at 1, 6, 24, 48 hours after surgery)
- Postoperative pain (numerical rating scale: 0 ~ 10)(at 1, 24, and 48 hours after surgery)
- Side effects of PCA (area and vomiting / hypotension / muscle weakness(at 1, 6, 24, 48 hours after surgery)
