NCT00209872Unknown4 期
Optimal Multimodal Analgesia in Abdominal Hysterectomy
适应症
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Postoperative abilities over time
研究概览
简要总结
The purpose of this study is to test the current standard of care (SOC) treatment for abdominal hysterectomy with a group receiving SOC minus epidural analgesia plus additional perioperative analgesics in terms of postoperative abilities, postoperative nausea and vomiting (PONV), pain and discharge time from the PACU (post-anaesthesia care unit).
详细描述
Aim of the study: to compare postoperative complaints (PONV, pain, etc) and PACU discharge time between two groups, for patients admitted for planned abdominal hysterectomy with or without BSO:
- A: standard of care (SOC) receiving paracetamol, celecoxib, epidural analgesia, dexamethasone, ondansetron and droperidol, and general anaesthesia with propofol, remifentanil and cisatracurium
- B: SOC with sham epidural analgesia, preoperative gabapentin, intraoperative lidocaine, s-ketamine and sufentanil
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
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Planned abdominal hysterectomy with or without BSO
- •Age above 18 years
- •Written informed consent
- •American Society of Anesthesiologists (ASA) class I-III
排除标准
- •Planned vaginal or laparoscopic hysterectomy
- •Hysterectomy as part of other surgery
- •Allergy to part of the treatment regimen
- •Previous reactions to opioids (nausea, cognition)
- •Previous inability to place correct epidural catheter
- •Severe state anxiety according to the OCAP or STAI
- •ASA class IV
- •Dependency on alcohol, opioids or central stimulants
- •Chronic pain condition
- •Hemorrhagic diathesis
- •Participation in another study
结局指标
主要结局
Postoperative abilities over time
Discharge time from PACU according to fixed criteria
Consumption of analgesics and antiemetics in the PACU
次要结局
- Degree of nursing requirements at the PACU
- General tolerability of the regimes
- Threshold for sensory perception and pain using the Pain Matcher device, pre- and postoperatively
研究者
研究点 (2)
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