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临床试验/NCT03813953
NCT03813953已完成不适用

The Effect of Analgesic Modalities on Long Term Outcomes Following Open Liver Resection

University of Edinburgh1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2019年3月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
160
试验地点
1
主要终点
Overall survival in months

研究概览

简要总结

The LIVER (Local Infiltration Versus Epidural after Liver Resection) and LIVER 2 (Local Infiltration Versus Epidural after Liver Resection 2) studies were randomised controlled trials that compared epidural analgesia with local anaesthetic wound infiltration as post-operative analgesia in patients undergoing open liver resection.

The overall findings of this trial were of similar rates of morbidity and pain control post-operatively but a reduced recovery time for the wound catheter group. As a result, wound catheter local anesthetic infiltration has become increasingly utilized in this unit and within other units throughout the country and worldwide.

Epidural use has been associated with improved long term outcomes following abdominal cancer surgery. This study is therefore a long term follow up study of the LIVER and LIVER 2 trials to assess survival between the two groups.

详细描述

The LIVER and LIVER 2 studies were randomised controlled trials that compared epidural analgesia with local anaesthetic wound infiltration as post-operative analgesia in patients undergoing open liver resection.

The overall findings of this trial were of similar rates of morbidity and pain control post-operatively but a reduced recovery time for the wound catheter group. As a result, wound catheter local anesthetic infiltration has become increasingly utilized in this unit and within other units throughout the country and worldwide.

There has been some evidence however, that epidural analgesia post-operatively can have a positive impact on long term survival in patients undergoing abdominal surgery for cancer. The reasons for this are not well established but it is proposed that the protective effect against the immunosuppression following major surgery that epidural has can aid in the cancer prevention process. There remains no randomised controlled trials looking at this subject in open liver surgery.

The aim of this study is to assess the overall and disease free survival of the patients who participated in the LIVER and LIVER 2 trials.

The primary outcome is 5 year overall survival. Data will be observed from electronic (or non electronic) patient records, information and statistics department data and general practice records as required.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
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 who participated in the LIVER and LIVER 2 trials who had diagnoses of a malignancy and underwent liver resection for this malignancy.

排除标准

  • •Patients who had liver resection for benign disease. Patients who participated in the LIVER/LIVER2 trials but who did not undergo resection.

研究组 & 干预措施

Epidural

Active Comparator

Conventional practice following liver resection

干预措施: Liver resection (Procedure)

Local Anaesthetic Wound Infiltration

Experimental

Wound catheter delivering local anaesthetic for 48 hours post-operatively following liver resection

干预措施: Liver resection (Procedure)

结局指标

主要结局

Overall survival in months

时间窗: 5 years

Number of months from the date of surgery to the date of death or the censor date

次要结局

  • Disease free survival(5 years)
  • overall survival(3 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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