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临床试验/NCT06254430
NCT06254430已完成不适用

Effects of Erector Spina Plan Block and Epidural Analgesia in Whipple Surgery

Ankara City Hospital Bilkent1 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2023年3月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
65
试验地点
1
主要终点
Postoperative visual analog scale(1-10)

研究概览

简要总结

Pancreatic surgery is generally a high-risk and difficult to manage perioperatively.

surgery. In pancreatic surgery, in addition to general anaesthesia, central blocks for analgesia and peripheral blocks are also preferred. In this study, in patients undergoing whipple surgery epidural and erector spina plan block (ESP) may cause intraoperative and postoperative pain, renal functions and haemodynamic variables.

详细描述

Pancreatic surgery and anaesthetic management is a difficult operation due to the anatomical location and function of the pancreas. Thoracic epidural anaesthesia/analgesia (TEA) in addition to general anaesthesia in upper abdominal surgeries such as pancreas, liver and stomach.Thoracic epidural analgesia (TEA) is the most widely used gold standard in this type of surgery.

TEA may cause haemodynamic changes in patients due to decreased sympathetic tone due to sympathetic nerve blockade. In elderly patients, bradycardia and hypotension is observed more frequently. Cardiovascular response decreases with age due to decreased cardiac reserve and deterioration of the autonomic nervous system and arteriolar structure. This can lead to this is because more segments are blocked than in younger patients. Pain control with thoracic epidural will provide pulmonary rehabilitation and rapid mobilisation. Accordingly, thromboembolic events, atelectasis and pulmonary infections are prevented. However, it has important unwanted side effects such as hypotension, dural puncture and contralateral block. All these disadvantages of TEA has increased interest in alternatives. Peripheral regional anaesthesia techniques have become more popular as a component of multimodal analgesia to avoid complications associated with epidural analgesia.

In 2016, ESP block, which is an ultrasound-controlled fascial plane block, was described. ESP block is considered to be an easier, effective and safer alternative to epidural and paravertebral blocks. The mechanism of action of ESP involves blockade of both dorsal and ventral branches, resulting in somatic and visceral analgesia.

Intraoperative and postoperative renal function may be impaired in upper abdominal surgeries. Acute kidney injury (AKI) is an important cause of postoperative mortality and morbidity. The most serious adverse factor is both surgical and anaesthesia-related AKI.

hypotension that may develop. The duties of the anaesthesiologist include maintaining perioperative renal function, predetermining the risk of AKI and taking necessary precautions. Considering the data in the literature, postoperative AKI Recent studies have shown that there is a link between inflammation and cancer. Studies reveal a relationship between cytokine and chemokine production and tumour growth, angiogenesis and metastatic capacity. Inflammatory cells and substances produced by inflammation affect cells in the peripheral blood. Platelets promote extravasation of circulating tumour cells. Neutrophils can also promote tumour adhesion and seeding by secreting growth factors into the peripheral circulation. However, lymphocytes can exert anti-tumour effects by inhibiting the proliferation and migration of tumour cells. From this point of view, SII (Systemic inflammation index) is a new prognostic factor obtained by measuring the number and ratio of neutrophils, platelets and lymphocytes in the peripheral blood of many tumours.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

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

入选标准

  • Patients undergoing whipple surgery,
  • ASA (The American Society of Anesthesiologists) I-III risk grup
  • Between the ages of 18-80

排除标准

  • Those who do not accept the transaction,
  • Serious cardiovascular disease,
  • Those for whom epidural anesthesia and peripheral blocks are contraindicated,
  • Those who have had spinal surgery,
  • Those who are allergic to one of the local anesthetics to be used,
  • Those whose hemoglobin value is below 10 g/dl) disease,
  • Those with drug and alcohol addiction,

结局指标

主要结局

Postoperative visual analog scale(1-10)

时间窗: at the postoperative 1. hour

the investigators aimed to compare postoperative visual analog scale of two groups.The visual pain scale is measured with a ruler from 0 to 10 cm. 0 indicates no pain 10 indicates severe pain

Intraoperative remifentayl consumption (microgram)

时间窗: peroperatively

Total amount of remifentanyl during the Intraoperative period

Rate of heart beat (beat/min)

时间窗: During the anesthesia, It will be evaluated at 1 hour intervals.

the investigators aimed to compare intraoperative pulse rate of two groups

Value of systolic blood pressure (mmHg)

时间窗: During the anesthesia, It will be evaluated at 1 hour intervals.

the investigators aimed to compare intraoperative systolic blood pressure of two groups

Rate of systemic inflammation index: SII (Systemic immune inflammatory index) is the formulation of the values of platelets, neutrophils and lymphocytes in peripheral blood as P X N / L = SII.

时间窗: At the preoperative and postoperative time points

the investigators aimed to compare postoperative systemic inflammation index of two groups.

次要结局

  • Amount of postoperative creatinine (mg/dl)(At the postoperative 24.hour)
  • Amount of postoperative urea (mg/L)(at the postoperative 24.hour)
  • incidence of death (percentage of )(at postoperative 1.year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ayça Özcan

Principal Investigator

Ankara City Hospital Bilkent

研究点 (1)

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