Effects of Intraoperative Total Intravenous Anaesthesia (TIVA) With Propofol Versus Inhalational Anaesthesia on Postoperative Pain After Hepatectomy: a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Pain assessed by numercial rating scales (NRS) pain scores
研究概览
简要总结
Propofol is a commonly used intravenous anaesthetic drugs both for induction and maintenance of general anaesthesia. Advantages of total intravenous anaesthesia (TIVA) with propofol include reduced nausea and vomiting, reduced atmospheric pollution, and better wake up profile. But the need for a reliable intravenous access, specialized pumps, pain on injection and potential concerns regarding awareness are potential disadvantages of TIVA propofol.
Results from clinical trials have not been consistent. Some randomized trials have shown improved analgesia with TIVA propofol, and some reported no significant difference. A meta-analysis found that propofol was associated with a statistically significant reduction pain scores 24 hours after surgery. However, the clinical effect size was small. Therefore, the usefulness of propofol as an analgesic adjunct is still inconclusive.
Whether TIVA propofol is useful in providing significant postoperative analgesia may be influenced by the type of surgery and accompanying analgesic regime. This agrees with the concept of procedure specific analgesia. Liver surgery produces moderate to severe pain as a result of an upper abdominal incision. Pain control can be difficult due to concerns with epidural analgesia in patients with potential clotting abnormalities and the effect of analgesic metabolism as a in patients with liver dysfunction. Results from our retrospective study showed that TIVA propofol was associated with reduced pain scores with coughing on postoperative days 1 and 2, and also reduced opioid consumption when compared with sevoflurane after liver surgery.
In this study, the investigators plan to conduct a randomized controlled trial to further determine whether TIVA propofol reduces acute postoperative pain and opioid consumption after hepatectomy.
详细描述
* Preoperative care
Assessment will be done at the preadmission clinic or at the general ward. Fasting for patients will start at midnight before operation. Sedative premedication will not be prescribed.
* Anaesthesia and intraoperative care
= Group S (sevoflurane) - Patients from group S will be anaesthetized by inhalational anaesthesia using sevoflurane, according to the following protocol:
On arrival to the operation theatre, a 20 or 22 gauge intravenous cannula will be inserted. Standard monitoring with pulse oximeter, non-invasive blood pressure, and three lead electrocardiogram will be applied prior to induction. Non-invasive blood pressure will be checked at least every 5 minutes throughout the operation.
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
- Double (Participant, Investigator)
盲法说明
Patients will not be aware of the type of anaesthesia they will receive. A separate blinded investigator will assess the patients after the operation. The anaesthetist providing general anaesthesia will be aware of the allocation, but s/he will not be involved in data collection.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA I to III
- •Scheduled for elective hepatectomy (left or right hepatectomy, segmentectomy, or wedge resection)
排除标准
- •Known drug allergy to propofol, opioids, non-steroidal anti-inflammatory drugs (NSAIDs) including COX-2 inhibitors, paracetamol, ketamine
- •Alcohol or drug abuse
- •Impaired renal function, defined as preoperative serum creatinine level over 120µmol/L
- •Impaired or retarded mental state
- •BMI > 35kg/m2
- •History of chronic pain
- •Pregnancy
- •Local infection
- •History of psychosis, delirium
- •Chronic opioid user
- •Patient refusal
研究组 & 干预措施
Group P
The patients in group (P) will be anaesthetized using total intravenous propofol.
干预措施: Propofol (Drug)
Group S
Patients in group (S) will be anaesthetized by inhalational anaesthesia using sevoflurane.
干预措施: Sevoflurane (Drug)
结局指标
主要结局
Pain assessed by numercial rating scales (NRS) pain scores
时间窗: at postoperative day 1
NRS pain scores (from 0-10, where 0 is the least satisfaction and 10 most satisfaction) will be recorded at rest and with coughing everyday.
次要结局
- PCA morphin consumption(from postoperative day 0 until postoperative day 5)
- Dihydrocodeine use(from postoperative day 0 until postoperative day 5)
- Side effects of analgesics(from postoperative day 0 until postoperative day 5)
研究者
Wong Sau Ching Stanley
Clinical Assistant Professor
The University of Hong Kong