Comparison of Analgesic Methods, and Their Effects on Patient Recovery, Following Liver Surgery (LIVER)
The Effects of Local Infiltration Versus Epidural on Recovery
The provision of adequate pain relief following major liver surgery is essential, not only for patient comfort, but for the prevention of complications, such as chest infection.
Commonly, pain relief in the first few days after surgery is provided by epidural analgesia. Drugs are delivered to the area around the spinal cord, through a fine plastic tube placed in the patients back, and this blocks sensation from the abdomen downwards, thereby providing effective pain relief without the need for opiate analgesia (e.g. morphine). Opiate analgesia can cause nausea, drowsiness and constipation, and its use should be minimised. Epidurals, however, can be associated with some problematic side effects. Low blood pressure is commonly encountered, and not only can its treatment be associated with complications, but patients are often confined to bed.
Mobility can also be limited if muscle function in the legs, (in addition to sensation), is inadvertently affected by the epidural drugs. Other problems associated with epidural use are the relatively common failure of the technique to provide adequate analgesia (20%), and some extremely rare but potentially disastrous complications of epidural insertion.
An alternative technique, is the provision of pain relief directly into the wound, via one or more multi-holed tubes(catheters), placed either in or close to the wound. This technique alone does not provide as effective analgesia as a functioning epidural, but when combined with other intravenous or oral analgesia, has been shown to be effective following a variety of surgical procedures.
It is hypothesised that, following major liver surgery, the use of this latter technique may result in superior outcome and faster recovery, when compared with epidural, by avoidance of the side effects and complications discussed above.
In this study, patients scheduled to undergo major liver surgery at the Royal Infirmary of Edinburgh with be randomly assigned to receive the first two days of pain relief either by epidural, or by wound catheter plus additional analgesia. Both groups will then receive an identical oral analgesic regime for the remainder of the hospital stay.
Outcomes of interest will include the quality of pain relief attained, patient mobility, frequency of complications, and overall recovery time.
研究概览
地位
条件
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Midlothian
-
Edinburgh、Midlothian、英国、EH16 4SA
- Department of Surgery, Royal Infirmary of Edinburgh
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Patients undergoing open hepatic resection for benign or malignant conditions.
- Able to understand the nature of the study and what will be required of them.
- Men and non-pregnant, non-lactating women.
- BMI 18-40.
Exclusion Criteria:
- Patients with contraindication to either epidural or wound catheter techniques.
- Inability to give written, informed consent.
- Patients with dementia or neurological impairment.
- Patients with pre-existing condition limiting mobility.
- Underlying cirrhotic liver disease.
- Jaundice (Bilirubin > 50 μmol/L).
- Liver resection combined with secondary surgical procedure.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Epidural
Patients will follow a standard optimised recovery protocol, including epidural analgesia for the first 48 hours postoperatively.
|
|
|
实验性的：Wound catheter
Patients will follow a standard optimised recovery protocol, but analgesia in the first 48 hours will be delivered through local anaesthetic wound catheters and additional patient-controlled analgesia, instead of epidural analgesia.
|
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Length of time to reach criteria for discharge from hospital.
大体时间：This will be assessed twice daily until criteria for dicharge from hospital are met.
|
This will be assessed twice daily until criteria for dicharge from hospital are met.
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Pain scores, assessed using numerical rating score (0 to 10).
大体时间：Assessed at 2, 6 & 12 hours following closure of wound, and daily thereafter until discharge from hospital, or day 7, whichever is sooner.
|
Assessed at 2, 6 & 12 hours following closure of wound, and daily thereafter until discharge from hospital, or day 7, whichever is sooner.
|
|
Nausea and sedation scores, assessed using numerical rating score (0 to 3).
大体时间：Assessed at 2, 6 & 12 hours following closure of wound, and daily thereafter until discharge from hospital, or day 7, whicever is sooner.
|
Assessed at 2, 6 & 12 hours following closure of wound, and daily thereafter until discharge from hospital, or day 7, whicever is sooner.
|
|
Sleep disturbance, assessed using numerical rating score (0 to 10).
大体时间：Assessed daily from the morning following surgery until discharge from hospital, or day 7, whichever is sooner.
|
Assessed daily from the morning following surgery until discharge from hospital, or day 7, whichever is sooner.
|
|
Volume of intravenous fluids received in the first 48 hours following operation (ml).
大体时间：Data collected daily for first 48 hours following operation.
|
Data collected daily for first 48 hours following operation.
|
|
Mobility (percentage of time spent lying / sitting, standing or walking, as measured by ActivPAL meter).
大体时间：From the end of the operative procedure until discharge from hospital, or day 7, whichever is sooner.
|
From the end of the operative procedure until discharge from hospital, or day 7, whichever is sooner.
|
|
Time to return of bowel function (days).
大体时间：Assessed daily until return of bowel function.
|
Assessed daily until return of bowel function.
|
|
Length of time to meet criteria for discharge from the High Dependency Unit.
大体时间：Assessed twice daily until criteria for discharge from the High Dependency Unit met.
|
Assessed twice daily until criteria for discharge from the High Dependency Unit met.
|
|
Complications (General and Technical).
大体时间：Assessed daily throughout hospital admission, and at outpatient review clinic 4-6 weeks following discharge from hospital.
|
Assessed daily throughout hospital admission, and at outpatient review clinic 4-6 weeks following discharge from hospital.
|
合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.