EUS-guided Celiac Plexus Neurolysis Using Ropivacaine Combined With Anhydrous Alcohol for the Treatment of Abdominal Pain in Pancreatic Cancer: a Prospective Multicenter Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- the incidence of serious complications
研究概览
简要总结
Studies have shown that injecting local anesthetics in areas rich in blood vessels increases the risk of drug injection into blood vessels by mistake and increases the systemic absorption of drugs, which may increase the incidence of central nervous system and cardiovascular system toxic events caused by local anesthetics.EUS-CPN-related complications have not been clearly associated with local anesthetic adverse events.However, EUS-CPN local anesthetic injection area is located around the beginning of the abdominal trunk with abundant large and small blood vessels. The choice of local anesthetics with higher safety than bupivacaine, such as ropivacaine, is of great significance to ensure the safety of eus-cpn, especially for eus-cpn beginners.At present, there are no reports on the application of ropivacaine in eus-cpn.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 18-75;
- •Athologically confirmed as pancreatic cancer and clinically evaluated as advanced and unresectable;
- •The visual analogue scale (VAS) for pain ≥ 4；
- •Never received treatment for peritoneal plexus lesion or block；
- •Voluntary signing of written informed consent
排除标准
- •Women during pregnancy；
- •Cannot or refuses to sign the informed consent；
- •Blood clotting disorder（PLT <50 × 103/μL, INR > 1.5）；
- •Celiac infection；
- •Severe esophageal or gastric varices and ulcers which may affect operation;
- •The anatomical variation of the abdominal trunk abdominal aorta and could not be accurately located;
- •Alcohol allergy
- •Severe cardiopulmonary dysfunction and inability to tolerate the risk of intravenous anesthesia;
- •History of mental illness;
- •Patients with other chronic and acute diseases with unstable conditions that are expected to affect the efficacy evaluation and completion of the study.
研究组 & 干预措施
ropivacaine
The patients will be carried on EUS-CPN with 10ml 0.75% ropivacaine with 10ml anhydrous alcohol
干预措施: EUS-guided celiac plexus neurolysis (Procedure)
bupivacaine
The patients will be carried on EUS-CPN with 10ml 0.75% bupivacaine with 10ml anhydrous alcohol
干预措施: EUS-guided celiac plexus neurolysis (Procedure)
结局指标
主要结局
the incidence of serious complications
时间窗: 2 weeks
Complications like perforation, infection, pancreatitis, hemorrhage and local anesthetic complications (epilepsy, arrhythmia), etc.
The effective rate of abdominal pain relief
时间窗: 2 weeks
Preoperative and postoperative pain scores of the patients will be compared to estimate the effective rate of abdominal pain relief.
次要结局
- Improvement of quality of life(1 month, 3 months, 6 months and 1 year)
研究者
Zhaoshen Li
chief of the Gastroenterology
Changhai Hospital