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临床试验/NCT03011359
NCT03011359已完成不适用

The Comparison of Postoperative Pain After Colon Resection in Intravenous

Yonsei University1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2018年6月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
66
试验地点
1
主要终点
pain

研究概览

简要总结

Colon resection is one of the major surgery, the postoperative pain is so severe that it is necessary to use additional analgesics as well as a patient controlled analgesia (PCA). The most common pain management of this surgery is the intravenous (IV) PCA. If it is relatively insufficient amount of narcotic analgesics ,in the case of IV PCA, may be failed to reduce the pain effectively. Consequently, it may result in the a lot of rescue analgesics use, which leads to the adverse effects in patients who are very sensitive to narcotic analgesics. And the patient's satisfaction to the PCA may be low.

For the recently released PCA instrument 'PAINSTOP', the investigators can specify the mode setting including total volume, flow rate (basal rate) per hour, bolus dose, and lock out time (LOT). Furthermore, this device can be set to optimize basal infusion (B.I), which is a new mode, so that the administered rate and amount of drug can be increased or decreased according to the patient's use of bolus button. Therefore, this PCA device can be implemented to the conventional mode, and added the function of automatically controlling the basal rate and administered amount of drug according to the use demand of the patient. However, since there are few studies related to this new mode of PCA, more research is needed in patients with postoperative pain.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Triple (Participant, Investigator, Outcomes Assessor)

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

  • The subjects who undergoing colon resection due to colon cancer
  • ASA class Ⅰ-Ⅲ
  • Written consents obtained to participate voluntarily in this clinical trial

排除标准

  • Sudden change of surgical plan
  • Patients who have the hypersensitivity to the pain killers including narcotics
  • Patients who are unable to express the degree of pain

研究组 & 干预措施

1) Conventional PCA mode

Experimental

(Mode setting; total volume: 140 ml, flow rate: 2 ml, bolus volume: 0.5 ml, and LOT: 15 minutes)

干预措施: Conventional PCA mode (Other)

2) Optimizing B.I PCA mode

Active Comparator

Optimizing Basal Infusion (New) PCA mode(Mode setting; total volume: 140 ml, flow rate: changable by patients' requirement, bolus volume: 0.5 ml, and LOT: 15 minutes)

干预措施: Optimizing B.I (New) PCA mode (Other)

结局指标

主要结局

pain

时间窗: At postoperative 6 hours

At 6 hours after surgery, the pain scores will be measured by numeric rating scale range from 0 to 10.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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