Will Intrathecal Analgesia Contribute to a Faster Recovery Compared With Epidural Analgesia After Open Surgery for Gynecological Cancer. An Open Controlled Randomized Study.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Length of Stay
研究概览
简要总结
The purpose of the study is to compare epidural analgesia and intrathecal analgesia for explorative laparotomy through a middle-line incision for gynecological cancer in a fast track program to se if there is any difference in recovery. Length of stay is analyzed together with self-rate quality of life.
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with gynecological cancer (suspected or verified) planned for explorative laparotomy through a middle-line incision with a curative purpose.
- •WHO performance status <
- •American Society of Anesthesiologists class 1-
- •Women that understand and can express themselves in Swedish.
- •Women that after verbal and written information accept participation in the study and have signed an informed consent.
排除标准
- •Women where surgery is expected to include part/s, other than the abdominal surgery, where intrathecal or epidural analgesia is not expected to be effective
- •Women with contra indications for intrathecal or epidural anesthesia.
- •Women who are physically disabled and therefore nor expected to be mobilized on the day after surgery in the same way as non-disabled.
- •Women with a mental retardation that makes it impossible to fill in the relevant questionnaires or makes it impossible to understand the meaning of participation, or if it is ethically doubtful to include the woman.
- •Women with psychiatric or mental disorder that according to the responsible physician makes it unsuitable to participate in the study .
研究组 & 干预措施
Epidural analgesia
The epidural anesthesia is applied at a low thoracic level, primarily Th10-Th11. A bolus dose of fentanyl together with a continuous infusion of bupivacain 2.5 mg/ml, fentanyl 1.8 µg/ml and epinephrine 2.5 µg/ml is used during surgery. Infusion rate is chosen by the attending anesthetist. Postoperatively the epidural anesthesia is continued until the morning of the third postoperative day using bupivacain 1 mg/ml, fentanyl 2 µg/ml and epinephrine 2µg/ml. Infusion rate is set by the responsible physician, maximum rate is 10 ml/hour.
干预措施: Epidural (Drug)
Intrathecal analgesia
The patient is given one intrathecal dose of plain bupivacaine (Marcain® spinal) 5 mg/ml, 15 mg together with morphine (Morphine Special®) 0,4 mg/ml, 0.2 mg and clonidine (Catapresan®) 150 µg/ml, 75 µg. The intrathecal mixture is given through a lumbal puncture at level L2/3, L3/4 or L4/5 before the induction of general anesthesia.
干预措施: Intrathecal (Drug)
结局指标
主要结局
Length of Stay
时间窗: Participants will be followed for the duration of hospital stay, an expected average of 4 days
From day of surgery (Day 0) until discharge after surgery
次要结局
- Change in Quality of Life(Preoperatively and until 6 weeks after surgery)
研究者
Lena Nilsson
MD. PhD. Assoc professor.
University Hospital, Linkoeping