Intraoperative Administration of Intravenous Morphine in Patients Undergoing Laparoscopic Cholecystectomy - a Retrospective, Observational, Quality-improvement Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Use of rescue analgesia.
研究概览
简要总结
The goal of this observational, quality improvement study is to compare the effect of a dose of morphine given during gall-bladder removal surgery. The main questions to answer are:
- Do participants, who are given given a dose of morphine during gall-bladder removal surgery, experience less pain after surgery?
- Does a dose of morphine during gall-bladder removal surgery cause more side effects? The investigators will compare the effects of two types of anesthesia: a) anesthesia without morphine during surgery, and b) anesthesia with morphine during surgery.
详细描述
The investigators will use Redcap secure web application (via Open Patient Data Explorative Network, a subsidiary under University Hospital of Odense, Denmark) for data collection and data management.
No sample size has been collected as per the observational design. The investigators expect to include an equal number in each study arm, as there has been no indication of change in indications for surgery type.
The investigators expect to use students T-test for comparison of groups. If possible logistic regression analyses will be undertaken.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients who have had elective laparoscopic cholecystectomy/planned gall-bladder removal surgery
排除标准
- •age limit as above
- •patients unable to give consent to anesthesia
- •patients unable to participate in pain scoring
- •patients with chronic pain syndromes, characterized by patients receiving regular analgesic treatment and patients with active or previous contact to pain clinic)
- •patients with active or previous substance abuse
- •emergency surgery
结局指标
主要结局
Use of rescue analgesia.
时间窗: 24 hours
Calculated as morphine equivalents.
次要结局
- Rescue antiemetic treatment in postoperative ward.(Up to 24 hours follow up.)
- Pain-score at arrival in postoperative ward.(24 hours)
- Pain-score at discharge from postoperative ward.(24 hours)
- Time in postoperative ward.(24 hours)
- Analgesic treatment in surgical ward if admitted(24 hours)
- Intraoperative opioid use.(24 hours)
- Hospital length of stay.(1 month)
- Emergence from anesthesia.(24 hours)
- Antiemetic treatment in surgical ward.(24 hours)
研究者
Sanne Vibe Nielsen
Principal investigator
Esbjerg Hospital - University Hospital of Southern Denmark