Postoperative Recovery and Comfort After Urologic Robotic Surgery: A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Quality of Recovery 15 (QoR-15) score
研究概览
简要总结
Previously published studies show that adding intrathecal morphine to general anesthesia can reduce the postoperative pain and length of stay (LOS) in varies types of surgery. A recent meta-analysis showed that the addition of intrathecal morphine at doses below 500µg did not increase the risk of respiratory depression compared with a control group receiving intravenous opioids. Epidural analgesia is uncommonly used for robot-assisted laparoscopic procedures due to the limited surgical trauma. In addition, the risks associated with the epidural itself such as infection and spinal hematoma are thought to outweigh its possible benefits for these procedures.
At Linkoping University Hospital a combination of general anesthesia and intrathecal morphine in robot-assisted laparoscopic radical prostatectomy and in robotic-assisted laparoscopic cystectomy is now routinely used in order to improve postoperative recovery. However whether this approach is beneficial in other types of robotic-assisted urological procedures is unknown.
Therefore the investigators aim to conduct a feasibility study for the use of intrathecal morphine combined with general anaesthesia in adult patients undergoing elective urologic laparoscopic robot-assisted surgery at Linkoping University Hospital. The investigators will include 30 patients in the study. The specific aims are to investigate the feasibility and sensitivity of Quality of Recovery 15 (QoR15), as an outcome tool measuring postoperative well-being in this patient cohort.
The investigators will also investigate the feasibility of other outcome measures such as postoperative pain, post-anesthesia care unit LOS, occurrence of pruritus and hospital LOS.
For planning of the timeframe of the future interventional study the investigators will use this feasibility study to examine the inclusion rate of study patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled for elective urologic robotic assisted laparoscopic surgery in Linkoping University Hospital
排除标准
- •Not expected to comprehend the written or verbal study information
- •Patient planned for robotic assisted laparoscoic prostatectomy or robotic assisted laparoscopic cystectomy
- •Acute surgery
- •ASA class >3
- •Major surgery on another organ planned at the same operation
- •Patient planned for a neuraxial blockade in addition to general anaesthesia.
- •Study personal not available
结局指标
主要结局
Change in Quality of Recovery 15 (QoR-15) score
时间窗: Preoperative, postoperative up to day 7
Quality of Recovery 15. A total of 15 questions each answered with a value from 0 to 10. The minimum value of the QoR-15 is 0 and the maximum value is 150. A higher value means a better outcome.
次要结局
- Return of bowel function(Up to postoperative day 7)
- PONV(Up to postoperative day 3)
- Postoperative complications(Up to postoperative day 30)
- Length of hospital stay(Up to 30 days)
- Postoperative pain(Up to postoperative day 3)
研究者
Martin Holmberg
Principal investigator
Linkoeping University