跳至主要内容
临床试验/NCT03430440
NCT03430440Unknown不适用

Comparison of Analgesic Effects According to Patient-controlled Epidural Analgesia Modes in Patients Undergoing Open Gastrectomy: a Randomized Controlled Trial

Yonsei University2 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2017年3月1日最近更新:
适应症
干预措施

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

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

Experimental

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

Active Comparator

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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