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临床试验/NCT04629612
NCT04629612已完成不适用

Regional Anesthesia in Non-intubated Breast Surgery, a Randomized Controlled Trial

Taipei Veterans General Hospital, Taiwan2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2020年11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
120
试验地点
2
主要终点
Post-operative opioid use

研究概览

简要总结

There is a trend that breast surgery can be done with peripheral nerve blockade and intravenous sedation, which reduces the side effects of general anesthesia such as nausea and vomiting, intubation discomfort and postoperative pain. The distribution of breast nerves is complex. Common nerve block methods are paravertebral blocks and pectoral nerve blocks. By monitoring the patient's heart rate variability change and measuring the patient's parasympathetic tone, the analgesic drug can be administered according to the patient's individual differences to avoid insufficient or excessive analgesic dose. The aim of this proposal is a prospective randomized controlled clinical trial is designed to evaluate changes in analgesia nociception index (ANI), surgical pleth index (SPI), postoperative opioid demand, and pain scores between patients who received regional anesthesia and those without in breast surgery patients under non-intubated surgery.

详细描述

Anesthesia has three elements: immobility, painlessness, and amnesia. To achieve these three factors depends on the balance between multiple factors, so multiple parameters need to be used for evaluation. In terms of subcortical function, pain indexes such as analgesia nociception index, surgical pleth index, etc. can be used to evaluate. By monitoring the parameters and comprehensive evaluation during the operation, the patient's condition can be fully understood. Opioids act on the central nervous system, making the nerve response slow and analgesic The effect is good, but there are many side effects, such as nausea and vomiting, drowsiness, respiratory depression, constipation, endocrine disorders, etc., and the central nervous system is suppressed by opioids, but the surrounding tissues are still damaged, releasing inflammatory mediators, causing immune dysfunction. Therefore, it is necessary to suppress inflammation and reduce the use of opioids, but also to effectively relieve pain. Nerve blockade is a powerful tool for this purpose. Local anesthetics are applied next to the nerves of the wound so that the pain signal cannot be transmitted to the central nervous system, reduce inflammatory mediators, reduce acute and chronic pain.

Breast surgery can be completed by peripheral nerve blockade and intravenous sedation, which can reduce the side effects of general anesthesia such as nausea and vomiting, intubation discomfort and postoperative pain. The distribution of breast nerves is complex, from the superficial cervical plexus, brachial nerve plexus, and thoracic vertebral nerves. At present, the commonly used nerve blocking methods include spinal nerve block, thoracic muscle block, brachial nerve block, and superficial nerve block. Blocking methods such as the cervical plexus, studies have shown that peripheral nerve blockade can reduce the amount of opioid analgesics during surgery.

This research plan is to design a randomized clinical trial to observe changes in the analgesic injury index (ANI), surgical pleth index (SPI), intraoperative and postoperative opiate demand, pain index, etc. inpatients with or without regional anesthesia under non-intubated breast surgery.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

Double blind

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Breast neoplasm require surgical resection of tumor
  • Surgical type: non-intubated breast surgery under intravenous anesthesia

排除标准

  • Contraindication for regional anesthesia: coagulopathy, infection
  • Previous breast surgery
  • Body mass index > 40
  • Chronic opioid use
  • Allergy to intravenous and regional anesthesia agents: Propofol, remifentanil, bupivacaine

结局指标

主要结局

Post-operative opioid use

时间窗: 60th to 72nd hour postoperatively

Total dose of post-operative morphine, tramadol, meperidine, etc calculated as morphine equivalent

次要结局

  • Intra-operative opioid use(From start of induction to completion of surgery, total of 1-2 hours)
  • Intra-operative analgesia nociception index(From start of induction to completion of surgery, total of 1-2 hours)
  • Intra-operative surgical pleth index(From start of induction to completion of surgery, total of 1-2 hours)
  • Post-operative nurse rated pain scale(72nd postoperative hour)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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