Comparison Between Epidural and Patient Controlled Analgesia on Immunological and Inflammatory Systems Following Radical Retropubic Prostatectomy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Natural Killer Cell activity
研究概览
简要总结
Several recently published retrospective studies show that regional anaesthesia (RA) can reduce cancer-related mortality following surgical treatment of colorectal, breast and prostate cancers and malignant melanoma. If these results are true, then the choice of perioperative pain management is as beneficial, or even better, than the current oncological therapies. This theory needs to be investigated in a prospective, randomized and controlled trail. We shall perform a prospective, randomized study comparing the effects of Thoracic epidural analgesia (TEA) or patient controlled analgesia (PCA) on postoperative immunological and inflammatory markers in order to understand whether the protective effects, if any, of regional analgesia are due to changes in these markers or whether the underlying mechanisms is not mediated via this stress signalling pathway.
详细描述
Methods
Thirty patients (ASA status 1-2) in the age group 50 - 75 years, undergoing elective radical retropubic prostatectomy would be included in this pilot study. The exact type of cancer, its staging, degree of spread to proximal or distant sites and the pathologic type of cancer would be recorded. Patients on chronic analgesic medication, endocrinologic and immunologic diseases, those with known allergy to LA and those where epidural catheter placement was contraindicated would be excluded. Patients would be allocated to one of three groups: General anesthesia combined with Epidural anesthesia during and after the operation (Group GE; n = 12), General anesthesia combined with Epidural during anesthesia and local anesthesia postoperatively (Group GL; n = 12), General anesthesia alone (Group GO; n = 10)
Anesthesia and Surgery
All patients would be premedicated with midazolam 0.1 mg/kg 15-30 min before planned surgery, which is a routine in our hospital. Paracetamol 1 g was given orally every 6 h starting with the first dose at the time of premedication. IV access would be attained in the preoperative holding area and further anxiolytic would be given as necessary intravenously.
Epidural technique
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 78 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •ASA physical status 1-2
- •Radical retropubic prostatectomy
排除标准
- •Chronic use of opiates
- •Contraindication to epidural analgesia
- •Allergy to component drugs
- •Chronic inflammatory diseases
- •Use of steroids perioperatively
研究组 & 干预措施
Thoracic Epidural Analgesia (TEA)
TEA is used for perioperative pain management, having been used both intra- and postoperatively, up to 48 h.
干预措施: Thoracic Epidural Analgesia (TEA) (Drug)
Patient controlled analgesia (PCA)
PCA is the standard of pain management and is usually used for up to 48 h postoperative for pain management following radical prostatectomy.
干预措施: Patient controlled analgesia (PCA) (Drug)
结局指标
主要结局
Natural Killer Cell activity
时间窗: 24 h postoperative
NK cells are of primary importance in the elimination of tumor target cells at the early stage of tumor development, up to and including tumor metastasis. Decreased NK cell function during the perioperative period is associated with an increased risk of mortality in cancer patients. The NK cell activity would be measured using a special assay called FANKIA
次要结局
- IL-2(24 h postoperatively)
- IL-6(24 h postoperatively)
- TNF alpha(24 h postoperatively)
- Serum cortisol(0 h postoperatively)
研究者
Anil Gupta
Associate Professor
Örebro University, Sweden