Continuous Local Anaesthetic Wound Infusion (CLoWI) Versus PCA Morphine for Pain Control After Major Abdominal Surgery:A Double Blinded, Randomized, Controlled, Non Inferiority Trial (CLoWI Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 4
- 主要终点
- To compare CLoWI and PCA (Morphine) in terms of post operative pain control
研究概览
简要总结
Major abdominal surgery is associated with significant complications which may lead to morbidity and mortality. Pain experienced after surgery affects the recovery from surgery.
Our study aims to evaluate the current gold standard of PCA morphine infusion against a continuous wound infusion (CLoWI). The use of CLoWI negates the side-effects of opioids, and will be the first randomised controlled trial to compare PCA (Morphine) with CLoWI-LA (Ropivacaine).
详细描述
Major intra-abdominal surgery represents one of the commonest groups of surgical procedures performed both worldwide and within Singapore. Common general surgical conditions requiring major intra-abdominal surgery include intestinal pathologies such as cancer, ischaemia, infection, haemorrhage and perforation.
Major surgery within the abdominal cavity is associated with significant complications which may be life threatening with an associated hospital mortality rate of as high as 20% for emergency surgery. Importantly, the recovery from this type of major surgery often entails significant pain and discomfort for the patient during healing of the abdominal wound and internal organs from tissue trauma associated with these surgical procedures.
Recent developments in major intra-abdominal surgery have demonstrated the importance of the early surgical recovery period where common postoperative complications including pain, chest infection, intestinal ileus and delerium are not only associated with prolonged hospital stay but are harbingers of poor long term surgical outcomes. Current recommendations for perioperative management of patients undergoing major intra-abdominal surgery stress the importance of high quality perioperative care to minimise these sequelae. Key features of these recommendations are to provide a pain free postoperative surgical recovery with minimal nausea and vomiting to facilitate early mobilisation and functional recovery from surgery.
Patient controlled analgesia (PCA) with opioids is the first line analgesia therapy currently used in the immediate post-operative period following major abdominal surgery. PCA with opioids has some inherent disadvantages that include side-effects of opioids such as nausea, vomiting, prolonged ileus, dizziness, hallucination and respiratory depression with the need for supplementary oxygen. This is most pertinent in elderly patients who are more prone to these side-effects in addition to being more likely to have difficulties in understanding how to use the PCA and so are more vulnerable to inadequate pain control. Consequently, there may be a delay in resuming mobility and discharge from hospital.
Continuous local wound infusion (CLoWI) with Ropivacaine that is delivered into the extraperitoneal plane via an ON-Q® (Halyard) infusion pump has been shown to be an effective analgesia post-operatively. The use of CLoWI negates the side-effects of opioids and furthermore, the small portable pump allows early ambulation with no requirement for supplementary oxygen. Previous published research has demonstrated the benefits of continuous local wound infusion with local anaesthesia in terms of postoperative analgesia and surgical recovery However, there are no randomized controlled trials comparing PCA versus continuous local wound infusion alone; this study will be the first randomised controlled trial to compare PCA (Morphine) with CLoWI-LA (Ropivacaine).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Planned for elective or urgent# open abdominal surgery
- •Abdominal Surgery may include the following procedures:
- •A) Urgent laparotomy for perforated viscus, intestinal obstruction. B) Elective abdominal surgery for upper and lower gastrointestinal surgery
- •Ability to provide informed consent. A signed and dated written informed consent prior to study participation.
- •Age 21 to 80 years for both males and females
排除标准
- •Female subject who is pregnant
- •Inability to comply with PCA instructions due to physical disabilities. For example, visual or hearing impairment, arthritis, peripheral neuropathy.
- •Known allergy to local anaesthetic or opioid drugs (Morphine).
- •Current or recent on opioid therapy. For example due to chronic pain illness, opioid (or other) drug abuse or recent surgery.
- •Severe comorbid diseases including liver cirrhosis, renal failure requiring dialysis, Grade 4 NYHA (New Yoke Heart Association) heart failure, respiratory illness requiring NIV (Non-Invasive Ventilation), etc.
- •Severe associated acute illness American Society of Anesthesiologists (ASA) Grade 4 or 5 where survival following surgery is not expected
结局指标
主要结局
To compare CLoWI and PCA (Morphine) in terms of post operative pain control
时间窗: 5 days
To determine if wither CLoWI or PCA will achieve better post-operative pain control based on a numerical rating score from 0 - 10
次要结局
- To compare CLoWI and PCA (Morphine) in terms of post operative complication rates associated with opioid usage(5 days)
- To compare CLoWI and PCA (Morphine) in terms of the length of postoperative hospital stay.(from the time of surgery till discharge, an average of 5 days)
