ACTRN12618000754246已完成3 期
A Double-Blind Randomised Placebo-Controlled Trial Assessing the Effect of Peri-Operative Intravenous Lignocaine and Post-Operative Lignocaine Neurovascular Plane Infusion on Natural Killer Cell Function in Laparoscopic Colorectal Cancer Surgery
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 107
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit(—)
- 性别
- All
入选标准
- •All patients with colorectal cancer undergoing elective or semi-elective laparoscopic colon resection at the John Hunter Hospital and Newcastle Private Hospital
排除标准
- •a. are under 18 years of age, or
- •b. refuse or are unable to give written informed consent to participate in the study, or
- •c. have had previous abdominal surgery where there is a significant chance of the procedure not being able to be completed in a laparoscopic manner, based in the clinical judgement of the operating surgeon, or
- •d. have severe renal impairment or
- •e. receive an epidural, spinal or other neuroaxial anaesthetic as determined by the Anaesthetist on day of surgery, or
- •f. Have a planned stoma formation or
- •a. Have received neoadjuvant chemo-radiotherapy or have been on immunosuppressive agents in the preceding 8 weeks including glucocorticoids (not including inhaled steroids), antimetabolites, cytostatics (eg platinum compounds), antimetabolites (eg methotrexate, mercaptopurine, azathioprine, 5FU, anthracyclines, cytotoxic antibiotics eg bleomycin) , TNF bindng proteins (eg infliximab), drugs acting on immunophilins or
- •b. Have known stage 4 colorectal cancer disease
- •c. have known immunological disease including leukaemia or
- •d. have known allergy or adverse reaction to lignocaine or opioid drugs or
- •e. pregnant or lactating or
- •f. have a history of arrhythmia or long QT syndrome associated with the drugs used in this trial, or
- •g. Are taking regular opiate narcotics pre-operatively
研究者
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