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临床试验/NCT05470166
NCT05470166已完成不适用

Lidocaine Infusion With Enhanced Recovery Program for Pancreatic Cancer Surgery: Effect on Pain and Patient Immunity

Alexandria University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年4月20日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Post-operative nociceptive pain assessment.

研究概览

简要总结

The whole world now is directed to implement strategies that enhance the patient's quality of life and prevent tumor relapse.

Enhanced recovery after pancreatic surgery (ERAPS) program was found to improve the quality of life as it is an evidence-based protocol designed to standardize and optimize perioperative medical care in order to reduce surgical trauma, perioperative physiological stress, organ dysfunction, reduction of clinical complications, length of hospital stay and the health costs together with increase of patient satisfaction.

lidocaine; it is an amide local anaesthetic Recently its use as intravenous perioperative infusion for abdominal cancer surgeries is encouraging, as it significantly reduces postoperative pain, opioid consumption and nausea and vomiting. it also promotes gastrointestinal function recovery, and shortens the postoperative hospital stay. In addition, lidocaine in particular can act directly and indirectly on pancreatic cancer cells and the tumor microenvironment.

The investigators suggest that IV lidocaine infusion in combination with ERAPS protocol may achieve better postoperative outcomes after pancreatic surgery for cancer.

详细描述

The whole world now is directed to implement strategies that enhance the patient's quality of life and prevent tumor relapse , so the Enhanced recovery after pancreatic surgery (ERAPS) program was found to improve the quality of life as it is an evidence-based protocol designed to standardize and optimize perioperative medical care in order to reduce surgical trauma, perioperative physiological stress, organ dysfunction, reduction of clinical complications, length of hospital stay and the health costs together with increase of patient satisfaction.

ERAPS was applied for pancreatic surgery in 2012, since that time 27 developed ERAPS items were evaluated, 5 of them got the highest level of evidence those include (avoiding hypothermia, use of wound catheters for continuous analgesia, antimicrobial, thromboprophylaxis protocols and preoperative nutritional interventions for patients with severe weight loss (15%). ERAS society encourages further researches to improve compliance and outcome and to confirm the benefit of current updated recommendations.

Many drugs had been used in the anaesthetic management of major abdominal surgeries and of which is lidocaine; it is an amide local anaesthetic commonly used for regional and neuraxial blocks. Recently its use as intravenous perioperative infusion for abdominal cancer surgeries is encouraging, as it significantly reduces postoperative pain, opioid consumption and nausea and vomiting. it also promotes gastrointestinal function recovery, and shortens the postoperative hospital stay.

In addition, lidocaine in particular can act directly and indirectly on pancreatic cancer cells and the tumor microenvironment. At the tumor level, lidocaine can induce apoptosis in cancer cells by inhibiting Src phosphorylation and reducing the expression of adhesion molecules. In the tumor microenvironment, lidocaine can enhance the activity of immune cells such as natural killer cells, which are responsible for directly attacking cancer cells. Furthermore the impact of lidocaine on post-operative opioid consumption could be another factor that reduces the opioid associated cancer progression.

Natural killer (NK) cells are cluster of differentiation 3 (CD3-) -cluster of differentiation 56 (CD56+) lymphocytes playing a pivotal role in the innate immune response against cancer. Their main purpose is identification and eradication of virus infected cells and metastatic cells. Diminished activity of NK cells is a predisposing factor for cancer recurrence. Preservation of innate immune function and the direct anti-inflammatory effects may be the cause of the protective effects of local anaesthetics and regional techniques.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
30 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 30-70 years
  • American society of anesthesiology (ASA) physical status class II;III.
  • Resectable pancreatic tumors.

排除标准

  • Patients with history of sensitivity to lidocaine,
  • Diabetic patients.
  • Body weight loss > 15%.
  • Opioid tolerant patient or patient receiving nonsteroidal anti-inflammatory drugs within 1 week of surgery or antiarrythmic drugs.
  • Cognitive dysfunction.
  • Any history of antitumor treatments or chemotherapy before surgery
  • Any contraindication for neuraxial anaesthesia.

研究组 & 干预措施

infusion of intraoperative lidocaine to patients undergoing whipple surgery

Experimental

lidocaine 1.5mg/kg infused as bolus, then 2mg/kg/hr through the operation

干预措施: Lidocaine IV (Drug)

saline infusion of same volume of lidocaine

Experimental

same amount of normal saline infused as bolus and infusion

干预措施: saline IV (Other)

结局指标

主要结局

Post-operative nociceptive pain assessment.

时间窗: 24 hours postoperative

post operative pain assessment using visual analogue scale (VAS), The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be.

次要结局

  • Effect on i tumor recurrence(pre-operative and 5 days postoperative)
  • Gastro-intestinal recovery.(up to 5 days postoperative)
  • Time to first ambulation(up to 5 days post-operative)
  • Total intra-operative fluid requirements.(intra-operative every 10 minutes)
  • Total analgesic consumption(up to 5 days post-operative)
  • Length of hospital stay in days(up to 5 days postoperative)
  • Perioperative complications(intraoperative and up to 5 days postoperative)
  • Effect on immune response(pre-operative and 5 days postoperative)
  • Effect on haemodynamics(intraoperative and 5 days post-operative)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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