Randomised Controlled Trial Comparing the Effects of Epidural, Spinal and PCA in Patients Undergoing Laparoscopic Colectomy.
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Length of hospital stay
研究概览
简要总结
The aim is to ascertain which method out of epidural, spinal or patient controlled analgesia (PCA) is the most appropriate in fluid optimised patients after laparoscopic colorectal surgery in terms of pain control, length of hospital stay and time for gut recovery. The second aim is to assess the physiological changes that occur when the patient is placed in steep trendelenberg position together with the creation of the pneumoperitoneum.
详细描述
Patients will be randomized into one of 3 groups - A, B or C. In order to remove the major confounding factor of hypovolaemia, all patients will have an oesophageal doppler inserted in order to achieve fluid optimisation. Each group will then either have an epidural, spinal or a PCA for post operative analgesia depending on the randomisation. All patients will follow a common postoperative care pathway to standardize the other factors.
Patients will be asked to report parameters including pain visual analogue score (VAS) chart three times a day. Recovery of bowel functions (passage of flatus, bowel movement, and diet intake), additional analgesia consumption, time to first ambulation, analgesia related side-effects and time to discharge will be recorded.
In addition whilst the patients fluid status is optimized during surgery with the oesophageal Doppler, the physiological changes that occur with the steep trendelenberg position and the pneumoperitoneum will be recorded.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with colorectal disease that requires a bowel resection who agree to have laparoscopic surgery with placement of an oesophageal doppler and a central line and who agree to be randomised with regards to a post operative analgesic regime.
排除标准
- •Patients will be excluded from the post operative analgesia trial if they have abnormal clotting, skin infection over or near the back, presence of neurological disorders or anatomical abnormalities of the vertebral column, or for a reason identified by the anaesthetist.
- •Patients will also be excluded if there is a contra-indication to oesophageal doppler such as oesophageal disease, recent oesophageal or upper airway surgery, moderate to severe aortic valve disease and bleeding diathesis.
研究组 & 干预措施
Epidural
Epidural
干预措施: epidural (Procedure)
2
Spinal
干预措施: Spinal (Procedure)
3
Patients in this limb receive a PCA
干预措施: PCA (Procedure)
结局指标
主要结局
Length of hospital stay
时间窗: Once the patient is safe to go home
次要结局
- Pain, time till flatus, time till bowels open, incidence of nausea and vomiting, quality of life(Once secondary outcomes are successful, patient can go home)