Intravenous Lidocaine for Pain Associated With Pancreatic Cancer and Chronic Pancreatitis (LIDOPAN)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Pain score
研究概览
简要总结
Pain is a major clinical problem for many patients with pancreatic cancer and chronic pancreatitis (CP).In pancreatic cancer, nearly 75% of patients suffer from pain at the time of diagnosis, with over 90% of patients in advanced stages. In CP, pain occurs in 80-90% of patients and strongly affects quality of life. For both conditions, the majority of pain is addressed using the WHO analgesic ladder. However, more invasive pain therapies are often necessary.
Currently, in several centers in the Netherlands, treatment with IV lidocaine is already used in clinical practice in patients with pancreatic cancer and CP. Based on practical experience, the majority of patients benefit from this therapy, however, its efficacy in terms of duration of pain relief, decrease in pain scores, increase in patient satisfaction and adverse events is unknown. Therefore, the aim of this study is to investigate the efficacy of monitored single intravenous infusion in patients with pancreatic cancer and CP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- 是
入选标准
- •Age 18 years or older;
- •NRS score ≥4 despite previous pain treatment with non-opioid analgesics, opioids or TCAs. Or pain treatment with non-opioid analgesics, opioids or TCAs with adequate effect on pain, but unable to reduce the opioids;
- •Diagnosis of CP based on the M-ANNHEIM diagnostic criteria;17
- •For pancreatic cancer:
- •Diagnosis of pancreatic cancer (all stages)
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-2;
- •Life expectancy ≥ 3 months;
- •Consensus of surgeon/gastroenterologist and anesthesiologist for suitability for treatment
排除标准
- •Patients with contra-indications for intravenous lidocaine i.e. medical history of non-adequate liver function, hypersensitivity to local anesthetics, New York Heart Association Class III or IV cardiac disease or myocardial infarction within the past 12 months, shock, and conduction abnormalities (defined as second and third degree atrioventricular (AV) blocks, or atrial fibrillation);
- •Patients who underwent invasive pain therapies: such as endoscopic treatment or surgery for chronic pancreatitis, and splanchnic nerves or coeliac plexus blocks, neurolysis, or PRF for pancreatic cancer.
研究组 & 干预措施
Intravenous lidocaine
Monitored intravenous lidocaine infusion for patients with CP and pancreatic cancer is already current practice in the participating centers. Patients undergo treatment in the recovery unit of the anesthesiology department, for early detection of possible, although highly unlikely adverse events such as anaphylactic reactions, arrhythmias or hypotension. At the recovery unit continuous monitoring is possible and treatment of the above mentioned side effects can be easily provided. Continuous monitoring includes a 3-lead ECG, saturation, and blood pressure control every 15 minutes.
干预措施: Lidocaine IV (Drug)
结局指标
主要结局
Pain score
时间窗: Directly after treatment
Assessed by the Brief Pain inventory (scale: 0-10, higher score indicate worse outcome)
次要结局
- Dose of intravenous lidocaine administered(During intervention)
- Number of total performed treatments with intravenous lidocaine per participant(During follow-up (six months))
- Pain score(Directly after treatment, two weeks, and after one-three-six months)
- Numer of participants with minor or major complications(During follow-up (six months))
- Dose reduction of opioids(During follow-up (six months))
- Effect of treatment(After two weeks, and one-three-six months)
- Pain score long term(After two weeks, and one-three-six months)
- Quality of life (SF-12)(Baseline, and after one-three-six months)
研究者
M.G. Besselink
prof. M.G. Besselink
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)